Tactile sensing and needle guidance device

ABSTRACT

Tactile sensing devices, systems, and methods to image a target tissue location are disclosed. When force is applied onto a tissue surface using the tactile sensing device, sensors of a sensor array output voltage signals to a computing device and display screen operatively connected to the sensor array. The sensor array relays its output voltage signals to the computing device, the computing device processes the output voltage signals, and an image of the output voltage signals is visualized on the display screen to help identify a target tissue insertion site.

CROSS-REFERENCE

This application is a continuation of U.S. application Ser. No.16/230,566, filed on Dec. 21, 2018, which is a continuation ofInternational Application No. PCT/US2018/057860, filed on Oct. 26, 2018,which claims benefit of U.S. Provisional Application No. 62/578,147,filed Oct. 27, 2017 and U.S. Provisional Application No. 62/700,505,filed Jul. 19, 2018, each of which are incorporated herein by referencein their entireties.

SUMMARY

Disclosed herein, in certain embodiments, are tactile sensing devices,comprising: a frame comprising a needle guide comprising a proximalopening and a distal opening and a track therebetween configured toguide a needle; and a slot in open connection with the needle guide, theslot comprising a first slot wall, a second slot wall, a slot openingand a slot terminus at the proximal opening of the needle guide; and asensor array, the sensor array comprising: a first sensor comprising afirst surface, a second sensor comprising a second surface, and a sensorarray slit aligned with the slot of the frame and extending from aboundary of the sensor array to the distal opening of the needle guide,wherein the distal opening is positioned in between the first sensor andthe second sensor, wherein the first sensor is configured to output afirst voltage signal in response to a first change in a first pressureapplied to the first surface, and the second sensor is configured tooutput a second voltage signal in response to a second change in asecond pressure applied to the second surface.

In some embodiments, the needle guide comprises a notch configured toreversibly and temporarily secure the needle in place during needleinsertion. In some embodiments, the needle guide is fixed. In someembodiments, the frame comprises a needle alignment guide. In someembodiments, the needle alignment guide is a notch or a marking on thesurface of the tactile sensing device. In some embodiments, the sensorarray is a matrix array. In some embodiments, the sensor array is aflexible sensor array. In some embodiments, the track is angled at atreatment angle ranging between about 40° to about 90° with respect tothe sensor array. In some embodiments, the treatment angle is a cephaladangle between about 0° to about 15° with respect to an individual. Insome embodiments, the slot is perpendicular to the needle guide. In someembodiments, the sensor array is attached to a sensor array attachmentarea. In some embodiments, the frame comprises a handle. In someembodiments, the handle is a curved handle, a power grip handle, or apinch grip. In some embodiments, the handle comprises a grip feature. Insome embodiments, the tactile sensing device comprises a pressure sensorconnector, the pressure sensor connector operatively connecting thetactile sensing device with a fluid pressure sensor. In someembodiments, the tactile sensing device comprises a scanhead comprisingthe sensor array and wherein the frame comprises a scanning track alongwhich the scanhead comprising the sensor array is configured to moverelative to the frame. In some embodiments, a part of the framesurrounding the needle guide is made out of clear plastic. In someembodiments, a posterior surface of the tactile sensing device has acurvature about a longitudinal axis. In some embodiments, the posteriorsurface of the tactile sensing device has a curvature about a lateralaxis. In some embodiments, the slot and the sensor array slit aresubstantially a same width from the boundary of the sensor array to theneedle guide distal opening. In some embodiments, the sensor array isadhered to a posterior surface of the tactile sensing device.

Disclosed herein, in certain embodiments, are tactile sensing systems,comprising: a frame comprising a sensor unit and an electronic unit; thesensor unit comprising: a needle guide comprising a proximal opening anda distal opening and a track therebetween configured to guide a needle;a slot in open connection with the needle guide, the slot comprising afirst slot wall, a second slot wall, an slot opening and a slot terminusat the proximal opening of the needle guide; and a sensor array, thesensor array comprising: a first sensor comprising a first surface, asecond sensor comprising a second surface, and a sensor array slitaligned with the slot of the frame and extending from a boundary of thesensor array to the distal opening of the needle guide, wherein thedistal opening is positioned in between the first sensor and the secondsensor, wherein the first sensor is configured to output a first voltagesignal in response to a first change in a first pressure applied to thefirst surface, and the second sensor is configured to output a secondvoltage signal in response to a second change in a second pressureapplied to the second surface, the electronic unit, comprising: adisplay screen operatively coupled to the sensor array, the displayscreen configured to display: a pressure map representing a targettissue location in an individual in need thereof based upon the firstvoltage signal and the second voltage signal from the sensor array and aprojected subcutaneous needle location to be inserted into theindividual; and a connector configured to operatively connect theelectronic unit to the sensor unit; and a computing device comprising aprocessor operatively coupled to the sensor unit and the electronicunit, and a non-transitory computer readable storage medium with acomputer program including instructions executable by the processorcausing the processor to: i) convert the first voltage signal and thesecond voltage signal received from the sensor array into the pressuremap and display the pressure map on the display screen and ii) calculatethe projected subcutaneous needle location to be inserted into theindividual and output the projected subcutaneous needle location on thedisplay screen.

In some embodiments, the needle guide comprises a notch configured toreversibly and temporarily secure the needle in the needle guide fromslipping along the slot during needle insertion. In some embodiments,the needle guide is fixed. In some embodiments, the frame comprises aneedle alignment guide. In some embodiments, the needle alignment guideis a notch or a marking on the surface of the tactile sensing device. Insome embodiments, the sensor array is a matrix array. In someembodiments, the sensor array is a flexible sensor array. In someembodiments, the track is angled at a treatment angle ranging betweenabout 40° to about 90° with respect to the sensor array. In someembodiments, the treatment angle is a cephalad angle between about 0° toabout 15° with respect to the individual. In some embodiments, the slotis perpendicular to the needle guide. In some embodiments, the sensorarray is attached to a sensor array attachment area. In someembodiments, the frame comprises a handle. In some embodiments, thehandle is a curved handle, a power grip handle, or a pinch grip. In someembodiments, the handle comprises a grip feature. In some embodiments,the tactile sensing device comprises a pressure sensor connector, thepressure sensor connector operatively connecting the tactile sensingdevice with a fluid pressure sensor. In some embodiments, the tactilesensing device comprises a scanhead comprising the sensor array andwherein the frame comprises a scanning track along which the scanheadcomprising the sensor array is configured to move relative to the frame.In some embodiments, a part of the frame surrounding the needle guide ismade out of clear plastic. In some embodiments, a posterior surface ofthe tactile sensing device has a curvature about a longitudinal axis. Insome embodiments, the posterior surface of the tactile sensing devicehas a curvature about a lateral axis. In some embodiments, the slot andthe sensor array slit are directly aligned with one another. In someembodiments, the sensor array is adhered to a posterior surface of thetactile sensing device. In some embodiments, the electronic unitcomprises a printed circuit board. In some embodiments, the tactilesensing device comprises a sleeve configured for receiving theelectronic unit. In some embodiments, the tactile sensing devicecomprises a power source. In some embodiments, the power source is abattery. In some embodiments, the battery is located underneath thedisplay screen. In some embodiments, the sensor unit or the electronicunit are disposable. In some embodiments, the sensor unit and theelectronic unit are reversibly connected. In some embodiments, thetactile sensing device comprises a wireless transmitter, the wirelesstransmitter operatively connected to the sensor array, for remotelytransmitting the first voltage signal generated by the first voltagesensor and the second voltage signal generated by the second sensor. Insome embodiments, the processor is configured with instructions todisplay the target tissue location and the projected subcutaneous needlelocation on the display screen in real time. In some embodiments, theprocessor is configured with instructions to display the target tissuelocation and the projected subcutaneous needle location on the displayscreen while the needle is advanced along the needle guide through thedistal opening toward the target tissue location.

Disclosed herein, in certain embodiments, are methods of positioning aneedle in the tactile sensing device, comprising: a) inserting theneedle into the slot opening; b) guiding the needle along an axis of theslot by sliding the needle in between the first slot wall and the secondslot wall towards the needle guide, c) contacting the needle with thetrack of needle guide, and d) sliding the needle along the track towardsthe distal opening of the needle guide.

Disclosed herein, in certain embodiments, are methods of positioning aneedle, comprising: a) inserting the needle into the needle guide of thetactile sensing device, b) contacting the needle with the track ofneedle guide, c) sliding the needle along the track towards the distalopening of the needle guide and into a patient at an angle defined bythe track, and d) removing the device while the needle is in the patientby guiding the device such that the needle is travels along the slotbetween the first slot wall and the second slot wall toward and out ofthe slot opening.

Disclosed herein, in certain embodiments, are tactile sensing devices,comprising: a frame comprising a needle guide comprising a proximalopening and a distal opening and a track therebetween configured toguide a needle; and a sensor array, the sensor array comprising: a firstsensor comprising a first surface and a second sensor comprising asecond surface, wherein the first sensor is configured to output a firstvoltage signal in response to a first change in a first pressure appliedto the first surface, and the second sensor is configured to output asecond voltage signal in response to a second change in a secondpressure applied to the second surface.

In some embodiments, the needle guide comprises a notch configured toreversibly and temporarily secure the needle in place during needleinsertion. In some embodiments, the needle guide is fixed. In someembodiments, the needle guide is reversibly attached to the tactilesensing device. In some embodiments, the frame comprises a needlealignment guide. In some embodiments, the needle alignment guide is anotch or a marking on the surface of the tactile sensing device. In someembodiments, the sensor array is a matrix array. In some embodiments,the sensor array is a flexible sensor array. In some embodiments, thetrack is angled at a treatment angle ranging between about 40° to about90° with respect to the sensor array. In some embodiments, the treatmentangle is a cephalad angle between about 0° to about 15° with respect toan individual. In some embodiments, the tactile sensing device comprisesa slot in open connection with the needle guide, the slot comprising afirst slot wall, a second slot wall, a slot opening and a slot terminusat the proximal opening of the needle guide. In some embodiments, theslot is perpendicular to the needle guide. In some embodiments, thesensor array comprises a sensor array slit aligned with the slot of theframe and extending from a boundary of the sensor array to the distalopening of the needle guide. In some embodiments, the slot and thesensor array slit are substantially a same width from the boundary ofthe sensor array to the needle guide distal opening. In someembodiments, the sensor array is attached to a sensor array attachmentarea. In some embodiments, the frame comprises a handle. In someembodiments, the handle is a curved handle, a power grip handle, or apinch grip. In some embodiments, the handle comprises a grip feature. Insome embodiments, the tactile sensing device comprises a pressure sensorconnector, the pressure sensor connector operatively connecting thetactile sensing device with a fluid pressure sensor. In someembodiments, the tactile sensing device comprises a scanhead comprisingthe sensor array and wherein the frame comprises a scanning track alongwhich the scanhead comprising the sensor array is configured to moverelative to the frame. In some embodiments, a part of the framesurrounding the needle guide is made out of clear plastic. In someembodiments, a posterior surface of the tactile sensing device has acurvature about a longitudinal axis. In some embodiments, the posteriorsurface of the tactile sensing device has a curvature about a lateralaxis. In some embodiments, the slot and the sensor array slit aresubstantially a same width from the boundary of the sensor array to theneedle guide distal opening. In some embodiments, the sensor array isadhered to a posterior surface of the tactile sensing device. In someembodiments, the distal opening is positioned in between the firstsensor and the second sensor.

Disclosed herein, in certain embodiments, are tactile sensing systems,comprising: a frame comprising a sensor unit and an electronic unit; thesensor unit comprising: a needle guide comprising a proximal opening anda distal opening and a track therebetween configured to guide a needle;and a sensor array, the sensor array comprising: a first sensorcomprising a first surface, a second sensor comprising a second surface,wherein the first sensor is configured to output a first voltage signalin response to a first change in a first pressure applied to the firstsurface, and the second sensor is configured to output a second voltagesignal in response to a second change in a second pressure applied tothe second surface, the electronic unit, comprising: a display screenoperatively coupled to the sensor array, the display screen configuredto display: a pressure map representing a target tissue location in anindividual in need thereof based upon the first voltage signal and thesecond voltage signal from the sensor array and a projected subcutaneousneedle location to be inserted into the individual; and a connectorconfigured to operatively connect the electronic unit to the sensorunit; and a computing device comprising a processor operatively coupledto the sensor unit and the electronic unit, and a non-transitorycomputer readable storage medium with a computer program includinginstructions executable by the processor causing the processor to: i)convert the first voltage signal and the second voltage signal receivedfrom the sensor array into the pressure map and display the pressure mapon the display screen and ii) calculate the projected subcutaneousneedle location to be inserted into the individual and output theprojected subcutaneous needle location on the display screen.

In some embodiments, the needle guide comprises a notch configured toreversibly and temporarily secure the needle in the needle guide fromslipping along the slot during needle insertion. In some embodiments,the needle guide is fixed. In some embodiments, the needle guide isreversibly attached to the tactile sensing device. In some embodiments,the frame comprises a needle alignment guide. In some embodiments, theneedle alignment guide is a notch or a marking on the surface of thetactile sensing device. In some embodiments, the sensor array is amatrix array. In some embodiments, the sensor array is a flexible sensorarray. In some embodiments, the track is angled at a treatment angleranging between about 40° to about 90° with respect to the sensor array.In some embodiments, the treatment angle is a cephalad angle betweenabout 0° to about 15° with respect to the individual. In someembodiments, the tactile sensing device comprises a slot in openconnection with the needle guide, the slot comprising a first slot wall,a second slot wall, a slot opening and a slot terminus at the proximalopening of the needle guide. In some embodiments, the slot isperpendicular to the needle guide. In some embodiments, the sensor arraycomprises a sensor array slit aligned with the slot of the frame andextending from a boundary of the sensor array to the distal opening ofthe needle guide. In some embodiments, the slot and the sensor arrayslit are substantially a same width from the boundary of the sensorarray to the needle guide distal opening. In some embodiments, thesensor array is attached to a sensor array attachment area. In someembodiments, the frame comprises a handle. In some embodiments, thehandle is a curved handle, a power grip handle, or a pinch grip. In someembodiments, the handle comprises a grip feature. In some embodiments,the tactile sensing device comprises a pressure sensor connector, thepressure sensor connector operatively connecting the tactile sensingdevice with a fluid pressure sensor. In some embodiments, the tactilesensing device comprises a scanhead comprising the sensor array andwherein the frame comprises a scanning track along which the scanheadcomprising the sensor array is configured to move relative to the frame.In some embodiments, a part of the frame surrounding the needle guide ismade out of clear plastic. In some embodiments, a posterior surface ofthe tactile sensing device has a curvature about a longitudinal axis. Insome embodiments, the posterior surface of the tactile sensing devicehas a curvature about a lateral axis. In some embodiments, the slot andthe sensor array slit are directly aligned with one another. In someembodiments, the sensor array is adhered to a posterior surface of thetactile sensing device. In some embodiments, the electronic unitcomprises a printed circuit board. In some embodiments, the tactilesensing device comprises a sleeve configured for receiving theelectronic unit. In some embodiments, the tactile sensing devicecomprises a power source. In some embodiments, the power source is abattery. In some embodiments, the battery is located underneath thedisplay screen. In some embodiments, the sensor unit or the electronicunit are disposable. In some embodiments, the sensor unit and theelectronic unit are reversibly connected. In some embodiments, thetactile sensing device comprises a wireless transmitter, the wirelesstransmitter operatively connected to the sensor array, for remotelytransmitting the first voltage signal generated by the first voltagesensor and the second voltage signal generated by the second sensor. Insome embodiments, the processor is configured with instructions todisplay the target tissue location and the projected subcutaneous needlelocation on the display screen in real time. In some embodiments, theprocessor is configured with instructions to display the target tissuelocation and the projected subcutaneous needle location on the displayscreen while the needle is advanced along the needle guide through thedistal opening toward the target tissue location. In some embodiments,the distal opening is positioned in between the first sensor and thesecond sensor.

Disclosed herein, in certain embodiments, are methods of positioning aneedle in the tactile sensing device, comprising: a) inserting theneedle into the needle guide opening; b) contacting the needle with thetrack of needle guide, and c) sliding the needle along the track towardsthe distal opening of the needle guide.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the subject matter disclosed herein are set forthwith particularity in the appended claims. A better understanding of thefeatures and advantages of the subject matter disclosed herein will beobtained by reference to the following detailed description that setsforth illustrative embodiments, in which the principles of the subjectmatter disclosed herein are utilized, and the accompanying drawings ofwhich:

FIGS. 1A and 1B illustrate a tactile sensing device with a needle guidecomprising a slot and track. FIG. 1A shows a perspective view of thetactile sensing device 100 with an exemplary output image displayed onits display screen 4. FIG. 1B shows an additional perspective view ofthe tactile sensing device 100.

FIGS. 2A and 2B illustrate an embodiment of a tactile sensing device 200comprising a lateral slot and a needle guide comprising a notch. FIG. 2Ashows a perspective view of the tactile sensing device 200 with anexemplary output image displayed on its display screen 4. FIG. 2B showsa front view of the tactile sensing device 200.

FIG. 3 exemplifies an embodiment of the tactile sensing device 300comprising a wide cutout alternatively called a slot herein and a notchwith a lip protruding from the slot wall to aid in retaining a needle inthe track during insertion of the needle into the subject.

FIGS. 4A and 4B show an embodiment of the tactile sensing device 400comprising a battery and a printed circuit board. FIG. 4A shows a frontview of the tactile sensing device 400. FIG. 4B shows a side, wire frameview of the tactile sensing device 400.

FIG. 5 shows an embodiment of the tactile sensing device 500 comprisingan extended handle.

FIG. 6 shows an embodiment of the tactile sensing device 600 comprisinga disposable sensor unit 32.

FIG. 7 shows an embodiment of the tactile sensing device 700 comprisingan enhanced pinch grip.

FIG. 8 shows an embodiment of the tactile sensing device 800 comprisingan exaggerated undercut grip.

FIG. 9 shows an embodiment of the tactile sensing device 900 comprisinga pinch grip control.

FIG. 10 shows an embodiment of the tactile sensing device 1000comprising an undercut body grip.

FIG. 11 shows an embodiment of the tactile sensing device 1100comprising a power grip.

FIGS. 12A, 12B, and 12C show an embodiment of the tactile sensing device1200 comprising an electronic unit 34 and a sensor unit 32 that includesthe handle 54. FIG. 12A shows a front view of the tactile sensing device1200 comprising a sliding sleeve and a sliding electronic unit 34. FIG.12B shows a front view of the tactile sensing device 1200 comprising ahandle comprising an indent specific for a left thumb. FIG. 12C shows afront view of the tactile sensing device 1200 comprising a snap-ondisposable sleeve.

FIG. 13 shows a needle being inserted into a spinal canal or an epiduralspace 100 using the tactile sensing device 1300.

FIG. 14 shows an exploded view of an embodiment tactile sensing device1400.

FIG. 15 shows an exploded view of the screen-printed force-sensitiveresistor (FSR) array 108.

FIG. 16 shows a perspective view of a screen-printed force-sensitiveresistor (FSR) array 108 being adhered onto the tactile sensing device1600.

FIG. 17 shows a computer control system that is programmed or otherwiseconfigured to implement methods provided herein.

FIGS. 18A-C show an embodiment rocker tactile sensing device. FIG. 18Ashows a perspective view of the tactile sensing device. FIG. 18B shows aside view of the tactile sensing device comprising a curved sensorapplicator. FIG. 18C shows a side, cutaway view of the tactile sensingdevice.

FIGS. 19A-C shows an embodiment curved sensor applicator and needleguide insert of the tactile sensing device comprising a rocker design.FIG. 19A shows an isometric view of an embodiment curved sensorapplicator. FIG. 19B shows a cutaway view of an embodiment needle guideinsert comprising a needle guide. FIG. 19C shows a front view of anembodiment needle guide insert comprising a needle guide.

FIGS. 20A-E show the workflow of an embodiment rocker tactile sensingdevice. FIG. 20A shows a user applying an embodiment rocker tactilesensing device against the skin surface of a patient. FIG. 20B shows theuser moving an embodiment rocker tactile sensing device in a rockingmotion. FIG. 20C shows the user identifying the correct needle insertionposition. FIG. 20D shows the user removing an embodiment handle. FIG.20E shows the user securing the needle with an embodiment needleretention gate 17.

FIGS. 21A-C show an embodiment slider tactile sensing device. FIG. 21Ashows an isometric view of an embodiment slider tactile sensing device.FIG. 21B shows a side, cutaway view of an embodiment slider tactilesensing device with an undepressed scanhead. FIG. 21C shows a side,cutaway view of an embodiment slider tactile sensing device with adepressed scanhead.

FIGS. 22A-C show an embodiment slider tactile sensing device scanheadsubassembly 23 including a scanning track 45 and locking rack andrelease button or scanning knob retention clip. FIG. 22A shows a front,isometric view of the scanhead subassembly. FIG. 22B shows a back,isometric view of the scanhead subassembly. FIG. 22C shows a back,cutaway view of the scanhead subassembly.

FIGS. 23A-B show assembled and assembly view embodiment of a carriageand scanning knob including two scanning knob retention clips of anembodiment slider tactile sensing device. FIG. 23A shows an isometricview of the scanhead subassembly. FIG. 23B shows an exploded view of thescanhead subassembly.

FIGS. 24A-C show embodiment scanning knobs for the tactile sensingdevice. FIG. 24A shows a scanning knob with ribs. FIG. 24B shows aconcave scanning knob. FIG. 24C shows a convex scanning knob.

FIGS. 25A-B show embodiment scanhead including a needle track having aproximal needle track opening that tapers to the distal needle trackopening. FIG. 25A shows an isometric view of the scanhead. FIG. 25Bshows the scanhead of FIG. 25A, cut away through the needle track.

FIGS. 26A-D show the workflow of how a user utilizes the tactile sensingdevice comprising the slider design when imaging a target tissuelocation of a patient. FIG. 26A shows a user inserting the scanning knobinto the tactile sensing device. FIG. 26B shows the user sliding thescanning knob. FIG. 26C shows the user identifying the correct needleinsertion position. FIG. 26D shows the user removing the scanning knob.

DETAILED DESCRIPTION

While preferred embodiments of the subject matter disclosed herein havebeen shown and described herein, it will be obvious to those skilled inthe art that such embodiments are provided by way of example only.Numerous variations, changes, and substitutions will now occur to thoseskilled in the art without departing from the subject matter disclosedherein. It should be understood that various alternatives to theembodiments of the subject matter disclosed herein may be employed inpracticing the subject matter disclosed herein. It is intended that thefollowing claims define the scope of the subject matter disclosed hereinand that methods and structures within the scope of these claims andtheir equivalents be covered thereby.

Certain Definitions

The terminology used herein is for the purpose of describing particularcases only and is not intended to be limiting. As used herein, thesingular forms “a”, “an” and “the” are intended to include the pluralforms as well, unless the context clearly indicates otherwise.Furthermore, to the extent that the terms “including”, “includes”,“having”, “has”, “with”, or variants thereof are used in either thedetailed description and/or the claims, such terms are intended to beinclusive in a manner similar to the term “comprising”.

The term “about” or “approximately” means within an acceptable errorrange for the particular value as determined by one of ordinary skill inthe art, which will depend in part on how the value is measured ordetermined, e.g., the limitations of the measurement system. In certainembodiments, the term “about” or “approximately” means within 1, 2, 3,or 4 standard deviations. In certain embodiments, the term “about” or“approximately” means within 30%, 25%, 20%, 15%, 10%, 9%, 8%, 7%, 6%,5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, or 0.05% of a given value or range. Incertain embodiments, the term “about” or “approximately” means within20.0 degrees, 15.0 degrees, 10.0 degrees, 9.0 degrees, 8.0 degrees, 7.0degrees, 6.0 degrees, 5.0 degrees, 4.0 degrees, 3.0 degrees, 2.0degrees, 1.0 degrees, 0.9 degrees, 0.8 degrees, 0.7 degrees, 0.6degrees, 0.5 degrees, 0.4 degrees, 0.3 degrees, 0.2 degrees, 0.1degrees, 0.09 degrees, 0.08 degrees, 0.07 degrees, 0.06 degrees, 0.05degrees, 0.04 degrees, 0.03 degrees, 0.02 degrees or 0.01 degrees of agiven value or range.

The terms “individual,” “patient,” or “subject” are usedinterchangeably. None of the terms require or are limited to situationcharacterized by the supervision (e.g. constant or intermittent) of ahealth care worker (e.g. a doctor, a registered nurse, a nursepractitioner, a physician's assistant, an orderly, or a hospice worker).

The terms “user,” “health care worker,” “doctor,” and “physician” areused interchangeably. These terms refer to any person that operates thedevices described herein. Additional non-liming examples of a userinclude “registered nurse,” “nurse practitioner,” and “physician'sassistant.”

The terms “intracranial pressure (ICP)” and “cerebrospinal fluid (CSF)pressure” are used interchangeably. ICP is the pressure inside a skulland thus, it is the pressure in the brain tissue and CSF.

The terms “lumbar puncture” and “spinal tap” and “spinal puncture” areused interchangeably herein. Generally speaking, a “spinal puncture” isused herein to refer to lumbar puncture, spinal tap, epidural spinalinjection, spinal injection, and/or neuraxial anesthesia, and thus isinterchangeably therewith. The use of any one of these terms herein doesnot limit the devices, systems, or methods described herein to only thestated use or type of injection, but is exemplary only and such uses andinterchangeable with any other type of injection or puncture for which adevice or system or method described herein would be helpful orappropriate.

The term “needle hub,” as used herein, refers to the hub at one end of aneedle that commonly attaches to a syringe. The shaft of the needle isan elongated, slender stem of the needle that extends from the needlehub and is beveled at the end opposite to the needle hub end.

The term “proximal,” as used herein, is defined as being closest ornearer to the user holding and/or operating the tactile sensing device,unless otherwise indicated. For example, a user pressing the tactilesensing device onto a patient.

The term “distal,” as used herein, is defined as being farthest to theuser holding and/or operating the tactile sensing device, unlessotherwise indicated. For example, pressing the tactile sensing deviceonto a patient.

The terms “frame” and “main housing frame” are used interchangeableherein.

Accessing a Target Tissue Location

Accessing a target tissue location, for example, the epidural orsubarachnoid space via a spinal puncture is a technically challengingprocedure that is performed quite commonly in the clinic, especially inthe Emergency Room. The procedure involves “blindly” landmarking, orlandmarking by manually palpating, the lumbar spine, to identify a gapbetween two spinous processes through which a needle is inserted intothe epidural or subarachnoid space for fluid collection or injection.The “blind” landmarking technique improves with time and practicetherefore, physicians with limited experience find the spinal punctureprocedure challenging. Furthermore, regardless of experience, the spinalpuncture procedure becomes difficult to perform with obese patients orpatients with a high body mass index (BMI) because their highaccumulation of subcutaneous adipose tissue prevents the physician toaccurately landmark the lumbar spine via manual palpation. Currentlandmarking techniques only have a 30% accuracy, making it necessary foran average of >4 attempts to properly puncture the space, and resultingin >25% of patients having traumatic spinal punctures and >32% ofpatients left with post-dural puncture headaches (PDPHs). Additionally,elderly patients or pregnant patients have limited flexibility and areunable to maximally flex the hips, knees, and back, as is requiredduring a spinal puncture procedure in order to increase the openingspace between the intervertebral disks.

Beyond just landmarking and localization, other functional steps ofperforming a diagnostic spinal puncture, where cerebrospinal fluid (CSF)samples are collected and intracranial pressure is measured, areseverely inefficient. In order to obtain an intracranial pressurereading, physicians use a two-piece manometer connected to a needle hubby a three-way stopcock, which requires estimation of fluid levels indetermining intracranial pressure. To simultaneously balance a manometerand one or more cerebrospinal fluid collection tubes requiressignificant dexterity and/or sometimes more than one pair of hands.Thus, the risk of CSF spillages is high and further increases the riskof contamination. Accordingly, there is a need for improved oralternative devices, methods, systems, and kits to perform a spinalpuncture.

There is also a need for improved or alternative devices, methods,systems and kits to visualize bone and non-bone structures at any giventarget tissue location. In view of these deficiencies in the currentstate of the art, the subject matter presented herein addresses theseand other needs. The devices, systems, and methods disclosed herein arehighly advantageous. Some examples of advantages provided by thedevices, systems, and methods disclosed herein include, but are notlimited to, providing highly accurate imaging system as means for needleguidance to a target tissue location, imaging a target tissue locationin real time, while a user simultaneously advances a needle into thetarget tissue location, and providing features that help guide, align,and secure the needle at a specific treatment angle.

Lumbar Punctures and Spinal Punctures

A spinal puncture (alternatively referred to as a lumbar puncture) is aninvasive procedure performed in a clinical setting for diagnostic ortherapeutic purposes. A diagnostic spinal puncture, also known as“spinal tap,” is one of the most commonly invasive tests performed inthe clinic. Every year, approximately 400,000 diagnostic spinalpunctures are performed in the United States. During a spinal puncture,cerebrospinal fluid is collected and in some cases, cerebrospinal fluid(CSF) opening pressure is measured. Therapeutic spinal punctures aremost commonly performed to deliver spinal anesthesia, intrathecalchemotherapeutics, intrathecal pain killers, intrathecal antibiotics,and contrast agents.

In some instances, a spinal puncture is performed with a patient in alateral decubitus position or lying down on their side, knees bent, andhead in a neutral position. In some instances, a spinal puncture isperformed with a patient upright, seated with the chin down and feetsupported. Aseptic technique is used when performing a spinal puncture.In some instances, to perform a spinal puncture, a practitioner performsa series of steps including: identifying an intraspineous process spacebetween the 4^(th) and 5^(th) lumbar vertebrae (L4 and L5), between L3and L4, or between L2 and L3; cleaning the patient's skin in the lumbararea with iodinated solution, ethanol or isopropyl alcohol, andchlorhexidine; administering a local anesthetic such as, but not limitedto, xylocaine or lidocaine, in a manner such that it raises a small blebon the skin; administering additional local anesthetic, such aslidocaine, to deeper subcutaneous and intraspinous tissues; slowlyinserting a spinal needle angling towards the patient's head until theepidural or subarachnoid space is entered.

A critical component of a spinal puncture is the recording ofintracranial (ICP) pressure, represented by the ultra-low pressure ofthe cerebrospinal fluid. ICP or cerebrospinal fluid pressure istypically in the 8-15 mmHg (10-20 mbar) range. Cerebrospinal fluidpressure is typically determined using a two-piece manometer attached toa 3-way stopcock valve which is connected to a spinal needle.

During a diagnostic spinal puncture, alternatively called a spinal tapor a spinal puncture, a needle is inserted between two lumbar vertebraeand into the spinal canal in order to remove a sample(s) ofcerebrospinal fluid (CSF), which surrounds the brain and the spinalcord. In some instances, the CSF is collected and its physical,chemical, microscopic, and infectious properties are inspected. Physicalproperties of CSF that are checked include: color, turbidity, andviscosity. Chemical components of CSF that are routinely tested forinclude glucose and proteins. However, additional testing includes:protein electrophoresis to distinguish different types of protein;immunoglobulin G (IgG) detection; myelin basic protein detection; lacticacid detection; lactate dehydrogenase detection; glutamine detection;C-reactive protein detection; tumor markers such as carcinoembryonicantigen (CEA), alpha-fetoprotein (AFP), and human chorionic gonadotropin(hCG); amyloid beta 42 (Aβ42) protein detection; and tau proteindetection. Microscopic examination of CSF comprises analyzing the samplefor total cell counts including red and white blood cells; additionally,in some instances, a cytology test is performed to determine thepresence or absence of abnormal cells such as tumor cells or immatureblood cells. Infectious tests performed include: CSF gram stain,culture, and sensitivity test to detect microorganisms and predict bestchoices for antimicrobial therapy; detection of viruses using polymerasechain reaction (PCR); detection of CSF cryptococcal antigen to detect afungal infection caused by yeast; detection of specific antibodies; CSFacid-fast bacilli (AFB) test to detect mycobacteria such asMycobacterium tuberculosis; detection of parasites; and CSF syphilistest.

In some instances, diagnostic spinal punctures are used to diagnose:bacterial, fungal, and viral infections including meningitis,encephalitis, and neurosyphilis or syphilis; bleeding around the brainor spinal cord including subarachnoid hemorrhages; inflammation of thebrain, spinal cord, or bone marrow including myelitis; cancer includingbrain cancer, spinal cord cancer, and leukemia; neurological disordersincluding demyelinating diseases such as multiple sclerosis anddemyelination polyneuropathy, Guillain-Barr syndrome, mitochondrialdisorders, leukencephalopathies, paraneoplastic syndromes, Reyesyndrome; headaches of unknown cause; and intracranial pressuredisorders including pseudotumor cerebri also known as idiopathicintracranial hypertension (IIH), spontaneous intracranial hypotension,and normal pressure hydrocephalus.

Therapeutic lumbar punctures (alternatively called therapeutic spinalpunctures) are performed in the same manner as diagnostic spinalpunctures however, instead of collecting a sample of CSF, a therapeuticagent is delivered to the subarachnoid space. In some embodiments,therapeutic agents delivered via a spinal puncture include but are notlimited to: anesthetics such as bupivacaine, lidocaine, tetracaine,procaine, ropivacaine, levobupivacaine, prilocaine, and cinchocaine;opioids such as morphine, fentanyl, diamorphine, buprenorphine, andpethidine or meperidine; non-opioids such as clonidine; chemotherapeuticagents such as methotrexate, cytarabine, hydrocortisone, and thiotepa;contrast agents or dyes such as iohexol, metrizamide, iopamidol,ioversol, iopromide, iodixanol, iolotran, and iodophenylundecylic acid;anti-spasmodic agents such as baclofen; antibiotics such as gentamicinsulphate; proteins such as idursulfase.

Tactile Sensing Devices and Systems

Disclosed herein, in certain embodiments, are tactile sensing devicescomprising: a) a frame comprising a needle guide, the needle guidehaving a proximal opening and a distal opening and a track therebetweenconfigured to guide a needle, the track comprising a notch configured toreversibly and/or temporarily secure the needle in place; wherein theneedle guide is in open connection with a slot such that a needle ismoved toward the track along the slot until the needle reaches the notchof the track, the slot comprising a first slot wall and a second slotwall configured to guide a needle towards the needle guide; and b) asensor array, the sensor array comprising: a first sensor comprising afirst surface, a second sensor comprising a second surface, and a sensorarray slit positioned in between the first sensor and the second sensor,the first sensor configured to output a first voltage signal in responseto a first change in a first pressure applied to the first surface, andthe second sensor configured to output a second voltage signal inresponse to a second change in a second pressure applied to the secondsurface; wherein the sensor array is coupled to and positioned directlyunderneath the needle guide.

Disclosed herein, in certain embodiments, are tactile sensing systems,comprising: a frame comprising a sensor unit and an electronic unit; thesensor unit comprising: i) a needle guide, the needle guide having aproximal opening and a distal opening and a track therebetweenconfigured to guide a needle, the track comprising a notch configured tosecure the needle in place; wherein the needle guide is in openconnection with a slot, the slot comprising a first slot wall and asecond slot wall configured to guide a needle towards the needle guide;and ii) a sensor array, the sensor array comprising: a first sensorcomprising a first surface, a second sensor comprising a second surface,and a sensor array slit positioned in between the first sensor and thesecond sensor, the first sensor configured to output a first voltagesignal in response to a first change in a first pressure applied to thefirst surface, and the second sensor configured to output a secondvoltage signal in response to a second change in a second pressureapplied to the second surface; wherein the sensor array is positioneddirectly underneath the needle guide; the electronic unit, comprising:i) a display screen operatively coupled to the sensor array, the displayscreen configured to display: a pressure map representing a targettissue location in an individual in need thereof based upon the firstvoltage signal and the second voltage signal from the sensor array and aprojected subcutaneous needle location to be inserted into theindividual; and ii) a connector configured to operatively connect theelectronic unit to the sensor unit; and a computing device comprising aprocessor operatively coupled to the sensor unit and the electronicunit, and a non-transitory computer readable storage medium with acomputer program including instructions executable by the processorcausing the processor to: i) convert the first voltage signal and thesecond voltage signal received from the sensor array into the pressuremap and display the pressure map on the display screen and ii) calculatethe projected subcutaneous needle location to be inserted into theindividual and output the projected needle location on the displayscreen.

FIGS. 1A and 1B show an illustration of one embodiment of the tactilesensing device 100. In some embodiments, the tactile sensing device 100comprises a sensor array (not shown in FIGS. 1A-B), a display screen 4,a needle guide 2, and a pressure sensor connector 12. In someembodiments, the tactile sensing device 100 is configured to image adesired target tissue location and guide a needle to the desired targettissue location. In some embodiments, the tactile sensing device 100provides the user with targeted needle placement. In some embodiments,the tactile sensing device 100 provides the user with visual needleguidance.

Target Tissue Location

In some embodiments, the tactile sensing device images a target tissuelocation. In some embodiments, the desired target tissue location is thebone marrow. In some embodiments, the desired target tissue location isthe epidural or subarachnoid space. In some embodiments, the desiredtarget tissue location is gap between two spinous processes. In someembodiments, the tactile sensing device images bone and non-bonestructures around a target tissue location. In some embodiments, thetactile sensing device images the lumbar vertebrae and the non-bonestructures surrounding the lumbar vertebrae. In some embodiments, thetactile sensing device images the sacral vertebrae and the non-bonestructures surrounding the sacral vertebrae. In some embodiments, thetactile sensing device images the lumbar and sacral vertebrae and thenon-bone structures surrounding the lumbar and sacral vertebrae. In someembodiments, the tactile sensing device images the spinous processes andthe non-bone structures surrounding the spinous processes. In someembodiments, the tactile sensing device images the L3 and L4 spinousprocesses and the non-bone structures surrounding the L3 and L4 spinousprocesses. In some embodiments, the tactile sensing device images the L4and L5 spinous processes and the non-bone structures surrounding the L4and L5 spinous processes. In some embodiments, the tactile sensingdevice images the L5 and S1 spinous processes and the non-bonestructures surrounding the L5 and S1 spinous processes.

In some embodiments, the tactile sensing device images a first andsecond bone and non-bone structures. In some embodiments, the tactilesensing device images a plurality of bone and non-bone structures. Insome embodiments, a bone structure is a rib. In some embodiments, a bonestructure is an articular surface. In some embodiments an articularsurface is a vertebral articulation, an articulation of a first bone ofa hand with a second bone of the hand, an elbow joint, a wrist joint, anaxillary articulation of a first bone of a shoulder with a second boneof the shoulder, a sternoclavicular joint, a temporomandibular joint, asacroiliac joint, a hip joint, a knee joint, or an articulations of afirst bone of a foot with a second bone of the foot. In some instances,a vertebral articulation is a spinous process. In some embodiments, anon-bone structure is subcutaneous tissue, a muscle, a ligament, adiposetissue, a cyst, or a cavity.

FIG. 1A shows a perspective view of the tactile sensing device 100. FIG.1B shows an additional perspective view of the tactile sensing device100 illustrating a user 28 actively using the tactile sensing device 100in conjunction with a needle 14 and a pressure sensor 16. The user 28 isshown holding the needle 14 with the right hand while holding thetactile sensing device 100 with the left hand. In some embodiments, theuser 28 holds the needle 14 with the left hand while holding the tactilesensing device 100 with the right hand. In some embodiments, the tactilesensing device 100 accommodates left and right handedness.

Needles

In some embodiments, the systems disclosed herein further comprise aneedle 14, a stylet, or a catheter. In some embodiments, the needle isan atraumatic, also known as pencil-point type needle, or a traumaticneedle, also known as a classic needle or a Quincke type needle. In someembodiments, the system further comprises a spinal needle. In someembodiments, the spinal needle is a Quincke spinal needle, a Whitacrespinal needle, or a Sprotte spinal needle. In some embodiments, thesystem further comprises an epidural needle. In some embodiments, theepidural needle is a Weiss epidural needle, a Tuohy epidural needle, ora Hustead epidural needle. In some embodiments, the needle incudes, byway of non-limiting examples, a 6-gauge needle, an 8-gauge needle, a13-gauge needle, a 15-gauge needle, a 17-gauge needle, an 18-gaugeneedle, a 19-gauge needle, a 20-gauge needle, a 21-gauge needle, a22-gauge needle, a 23-gauge needle, a 24-gauge needle, a 25-gaugeneedle, a 26-gauge needle, a 27-gauge needle, a 28-gauge needle, a29-gauge needle, a 30-gauge needle, a 31-gauge needle, and a 32-gaugeneedle. In some embodiments, the needle is a spinal needle rangingbetween 1-10 inches in length. In some embodiments, the needle containsa stylet, also known as an obturator or an introducer, which is a finewire, a slender probe, or a solid rod with a metal hub fitted to match aneedle's bevel. In diagnostic spinal punctures, a stylet is withdrawnfrom the needle to allow cerebrospinal fluid to flow out from the spinalcanal and through the needle hub.

In some embodiments, the system further comprises a catheter. In someembodiments, the catheter is an epidural tunneled catheter, which isimplanted into the epidural space as a medication delivery port. In someembodiments, the catheter is used to monitor intracranial pressureduring a diagnostic spinal puncture procedure. In some embodiments, thecatheter is used as means to continuously remove cerebrospinal fluid andrelieve pressure on the brain of a patient suffering from hydrocephalus.

In some embodiments, the pressure sensor 16 is operatively connected tothe tactile sensing device 100 by a pressure sensor cable 18 thatoperatively couples the pressure sensor 16 to the tactile sensing device100 via a pressure sensor connector 12. In some embodiments, thepressure sensor connector 12 operatively connects the tactile sensingdevice with a fluid pressure sensor. In some embodiments, the pressuresensor connector 12 is located distally away from the needle guide 2. Insome embodiments, the pressure sensor connector 12 is a male connector.In some embodiments, the pressure sensor connector 12 is a femaleconnector. In some embodiments, the pressure sensor connector 12 is apressure sensor port.

In some embodiments, pressure sensor 16 is operatively connected to thetactile sensing device 100 and configured to measure a cerebrospinalfluid pressure. In some embodiments, the pressure sensor is anelectronic pressure sensor. In some embodiments, the electronic pressuresensor is medical grade. In some embodiments, the electronic pressuresensor is a Honeywell TruStability®, board mount pressure sensor, whichis capable of sensing 0-60 mbar. In some embodiments, the electronicpressure sensor is an uncompensated and unamplified piezoresistivesilicon pressure sensor. In some embodiments, the pressure sensor 16provides feedback of internal needle pressure during needle insertion.

In some embodiments, the pressure sensor 16 is a digital pressuresensor. In some embodiments, pressure sensor 16 is a pressure gauge. Insome instances, pressure sensor 16 is a piezoresistive, capacitive,electromagnetic, piezoelectric, optical, or potentiometric pressuresensor. In some embodiments, a cerebrospinal fluid pressure measuredwith the pressure sensor 16 is displayed digitally. In some embodiments,a cerebrospinal fluid pressure measured with pressure sensor 16 isdisplayed on display screen 4 in real-time. In some embodiments, thedisplay screen 4 provides visual needle guidance. In some embodiments, acerebrospinal fluid pressure measured with the pressure sensor 16 isdisplayed digitally on an external display screen. In some embodiments,a cerebrospinal fluid pressure measured with the pressure sensor 16 isdisplayed digitally on an external display screen of a computing deviceoperatively connected to the tactile sensing device 100. In someembodiments, a cerebrospinal fluid pressure measured with pressuresensor 16 is displayed on display screen 4 in real-time, while user 28simultaneous advances the needle 14 into a desired target tissuelocation.

In some embodiments, once the needle is guided to and inserted into adesired target tissue location and the tactile sensing device 100 is nolonger needed, user 28 slides the tactile sensing device 100 distallyaway from himself or herself in order to maintain the needle in placewhile removing the tactile sensing device 100 and optionally disconnectsthe pressure sensor 16.

In some embodiments, the tactile sensing device 100 comprises a mainhousing frame 19. In some embodiments, the main housing frame 19 is thehousing of the tactile sensing device 100. In some embodiments, the mainhousing frame 19 protects internal elements of the tactile sensingdevice 100 such as, but not limited to, electric circuitry, a powersource, and sensor array electric connections. In some embodiments, themain housing frame 19 is composed of a plastic or elastomer materialincluding, but not limited to: polyethylene; polypropylene; polystyrene;polyester; polylactic acid (PLA); polycarbonate, polyvinyl chloride,polyethersulfone, polyacrylate or acrylic or polymethylmethacrylate(PMMA); polysulfone; polyetheretherketone (PEEK); thermoplasticelastomers or thermoplastic urethanes; or poly-p-xylylene or parylene.

In some embodiments, the main housing frame 19 comprises an electronicunit 34 and a sensor unit 32, as shown in FIG. 1B. In some embodiments,the main housing frame 19 encompasses, surrounds, protects, supports,encases, or houses the electronic unit 34 and the sensor unit 32. Insome embodiments, the electronic unit 34 is disposable. In someembodiments, the electronic unit 34 is reusable. In some embodiments,the electronic unit 34 is durable. In some embodiments, the tactilesensing device 100 comprises a sleeve (not shown in FIGS. 1A-B) that isconfigured to receive the electronic unit 34. In some embodiments, thesleeve is a vacuum-formed sleeve. In some embodiments, the sleeve issterile. In some embodiments, the sleeve is composed of a plastic orelastomer material including, but not limited to: polyethylene;polypropylene; polystyrene; polyester; polylactic acid (PLA);polycarbonate, polyvinyl chloride, polyethersulfone, polyacrylate oracrylic or polymethylmethacrylate (PMMA); polysulfone;polyetheretherketone (PEEK); thermoplastic elastomers or thermoplasticurethanes; or poly-p-xylylene or parylene. In some embodiments, thesleeve is composed of a rubber material including, but not limited to:silicone rubber, natural rubber, acrylonitrile-butadiene rubber,hydrogenated acrylonitrile-butadiene rubber, ethylene propylene dienerubber, fluorocarbon rubber, chloroprene rubber, fluorosilicone rubber,polyacrylate rubber, ethylene acrylic rubber, styrene-butadiene rubber,polyester urethane rubber, or polyether urethane rubber. In someembodiments, a part of the main housing frame 19 surrounding the needleguide 2 is made out of clear plastic. In some embodiments, the mainhousing frame 19 is made out of clear plastic. In some embodiments,having the main housing frame 19 or part of the main housing frame 19near the needle guide be made out of clear plastic, enables user 28 tobetter visualize and guide the needle 14 as it penetrates the skin ofthe individual. In some embodiments, the frame 20 comprises a handle(not shown in FIGS. 1A-B). In some embodiments, the handle is a curvedhandle, a power grip handle, or a pinch grip. In some embodiments, thehandle comprises a grip feature.

In some embodiments, the sensor unit has a length 91, as shown in FIG.1A. In some embodiments, the length 91 of the sensor unit is about 130mm. In some embodiments, the length 91 of the sensor unit is about 100mm. In some embodiments, the length 91 of the sensor unit is about 50mm. In some embodiments, the length 91 of the sensor unit is about 150mm. In some embodiments, the length 91 of the sensor unit is about 25mm. In some embodiments, the length 91 of the sensor unit is about 200mm.

In some embodiments, the sensor unit has a width 93, as shown in FIG.1A. In some embodiments, the width 93 of the sensor unit is at leastabout 25 mm to about 200 mm at most. In some embodiments, the width 93of the sensor unit is at least about 25 mm to about 150 mm at most. Insome embodiments, the sensor unit is at least about 25 mm to about 130mm at most. In some embodiments, the width 93 of the sensor unit is atleast about 25 mm to about 50 mm at most. In some embodiments, the width93 of the sensor unit is at least about 50 mm to about 200 mm at most.In some embodiments, the width 93 of the sensor unit is at least about50 mm to about 150 mm at most. In some embodiments, the width 93 of thesensor unit is at least about 50 mm to about 130 mm at most. In someembodiments, the width 93 of the sensor unit is at least about 130 mm toabout 200 mm at most. In some embodiments, the width 93 of the sensorunit is at least about 130 mm to about 150 mm at most. In someembodiments, the width 93 of the sensor unit is at least about 150 mm toabout 200 mm at most.

In some embodiments, the electronic unit 34 comprises the display screen4. In some embodiments, the display screen 4 is operatively coupled tothe sensor array (not shown in FIGS. 1A-B). In some embodiments, sensorarray 24 is located on the posterior surface of the tactile sensingdevice 100. In some embodiments, sensor array 24 is coupled to theposterior surface of the tactile sensing device 100. In someembodiments, sensor array 24 is adhered to the posterior surface of thetactile sensing device 100. In some embodiments, sensor array 24 isconnected to the posterior surface of the tactile sensing device 100. Insome embodiments, the posterior surface of the tactile sensing device100 has a curvature about a longitudinal axis (not shown in FIGS. 1A-B).In some embodiments, the posterior surface of the tactile sensing device100 has a curvature about a lateral axis (not shown in FIGS. 1A-B). Insome embodiments, the curvature about a longitudinal axis is designed toreduce adverse effects of surrounding muscle. In some embodiments, thecurvature about a lateral axis helps the user comprehend the need torock the device in instances where there is significant spinal flexion.

Sensor Arrays

In some embodiments, the tactile sensing device comprises an array ofsensors. In some embodiments, the sensor array is a tactile sensorarray. In some embodiments, the sensor array comprises sensors that arepiezoresistive sensors. In some embodiments, the sensor array comprisessensors are piezoelectric sensors. In some embodiments, the sensor arraycomprises sensors are piezoresistive sensors. In some embodiments, thesensor array comprises sensors that are optical sensors. In someembodiments, the sensor array comprises sensors that are electromagneticsensors. In some embodiments, the sensor array comprises sensors thatare capacitive sensors. In some embodiments, the sensor array comprisessensors that are potentiometric sensors.

In some embodiments, the sensor array 8 comprises pressure sensors. Insome embodiments, the pressure sensors are force-sensitive resistors.Force-sensitive resistors (FSRs) change their resistance in response toa change in pressure applied to their surface. In some embodiments, theforce-sensitive resistors decrease their resistance with an increase inpressure applied the surface of the sensor. In some embodiments, thesensor array comprises at least one sensor configured to output a signalin response to a change in pressure applied to its surface.Force-sensitive resistors are two wire devices with a resistance thatdepends on applied force. In some embodiments, the force-sensitiveresistors comprise a voltage divider. In some embodiments, the voltagedivider outputs a voltage value that is correlated to the resistance;thus, the output voltage value also changes in response to a pressureapplied to the surface of the sensor. In some embodiments, an increasein voltage indicates an increase in a pressure applied to the surface ofthe sensor. In some instances, the force-sensitive resistors outputvoltage signals. In some embodiments, the array of force-sensitiveresistors is a 6×3 array comprising eighteen force-sensitive resistors.In some embodiments, the array of force-sensitive resistors is an 8×4array comprising thirty two force-sensitive resistors. In someembodiments, the size of the array of force-sensitive resistors isdependent upon the surface area of the individual's body to be examined.In some embodiments, the array of force-sensitive resistors isconfigured in a way that is sufficient to visualize the bone andnon-bone structures in the individual.

In some embodiments, the sensor array is a screen-printed pressuresensor array. In some embodiments, the screen-printed pressure sensorarray is also known as a matrix. In some embodiments, screen-printedpressure sensor arrays offer enhanced construction, resolution,sensitivity, and customizability, all at a reduced cost. In someembodiments, the screen-printed pressure sensor array comprises aThruMode configuration. As used herein, a ThruMode configuration refersto an array comprising two parallel sheets, one with conductive rows;the other with conductive columns; the locations at which these overlapform sensing cells (sensels). In some embodiments, the screen-printedpressure sensor array comprises two parallel sheets, one with conductiverows; the other with conductive columns; the locations at which theseoverlap form sensing cells (sensels). In some embodiments, thescreen-printed pressure sensor array comprises a ShuntModeconfiguration. In some embodiments, the drive electronics to supportthese arrays necessitate a 16-line shift register and 16-channelmultiplexer. In some embodiments, the 16-line shift register and16-channel multiplexer are driven by a microcontrolled.

In some embodiments, the sensor array is an array of sensor elementsalso known as “sensels.” In some embodiments, the sensels are notdiscrete sensors. In some embodiments, the sensor elements or senselsare configured to connect to each other. In some embodiments, the sensorelements are arranged in a grid, with each sensor element (or “sensel”)located at the intersection of a row and column. In some embodiments,the rows and columns are pinned out, rather than individual sensorsbeing pinned out, as is the case with an array of discrete sensors. Insome embodiments, the sensor array is an array of cells. In someembodiments, the sensor array is an array of sensing cells. In someembodiments, the sensor array slit is positioned between two rows ofsensels. In some embodiments, the sensor array slit is positionedbetween two columns of sensels. In some embodiments, the sensor arrayslit is within the bounds of the sensor array, and/or within the boundsof the sensor array outer edges, and/or within the edges bounding of thesensor array. In some embodiments, the distal opening of the needleguide opening is positioned between two rows of sensels. In someembodiments, the distal opening of the needle guide is positionedbetween two columns of sensels. In some embodiments the distal openingof the needle guide is within the bounds of the sensor array, and/orwithin the bounds of the sensor array outer edges, and/or within theedges bounding of the sensor array.

In some embodiments, the screen-printed pressure sensor array comprisesa plurality of sensors. In some embodiments, the sensors are sensingelements or sensels. In some embodiments, the sensels compriseinterdigitated fingers. In some embodiments, the screen-printed pressuresensor array is a 10×5 array. In some embodiments, the screen-printedpressure sensor array comprises about 10 columns of sensels and about 5rows of sensels. In some embodiments, the screen-printed pressure sensorarray comprises about 5 columns of sensels and about 10 rows of sensels.In some embodiments, the screen-printed pressure sensor array isdesigned to accommodate a slot for needle guidance and device removal.In some embodiments, the slot interrupts the sensor array. In someembodiments, the slot extends from a bounding edge of the array to thedistal opening of the track, and is sized and configured to allow theneedle to stay in place once inserted into the subject while the deviceitself is removed from the treatment area on the subject. That is, thespacing at the distal end of the slot is designed to accommodate aneedle, which is angled at a range of 0-30 degrees cephalad. Forexample, in some embodiments, the slot comprises a minimum width from afirst slot wall to a second slot wall of 0.5 mm to 15 mm, from 0.5 mm to10 mm, from 0.5 mm to 6 mm, from 0.25 mm to 10 mm, from 0.25 mm to 5 mm,about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, 2 mm, 3 mm, 2.5 mm,1.5 mm or about 1-3 mm. For example, in some embodiments, the slotcomprises a terminus width at the slot terminus from a first slot wallto a second slot wall of 0.5 mm to 15 mm, from 0.5 mm to 10 mm, from 0.5mm to 6 mm, from 0.25 mm to 10 mm, from 0.25 mm to 5 mm, about 1.5 mm,about 2 mm, about 2.5 mm, about 3 mm, 2 mm, 3 mm, 2.5 mm, 1.5 mm orabout 1-3 mm. For example, in some embodiments, the slot comprises anotch width at the track from a first slot wall to the notch at thedistal opening of 0.5 mm to 15 mm, from 0.5 mm to 10 mm, from 0.5 mm to6 mm, from 0.25 mm to 10 mm, from 0.25 mm to 5 mm, about 1.5 mm, about 2mm, about 2.5 mm, about 3 mm, 2 mm, 3 mm, 2.5 mm, 1.5 mm or about 1-3mm. For example, in some embodiments, the slot comprises a distal trackwidth at the distal opening of the track from a first slot wall to thedistal opening of the track of 0.5 mm to 15 mm, from 0.5 mm to 10 mm,from 0.5 mm to 6 mm, from 0.25 mm to 10 mm, from 0.25 mm to 5 mm, about1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, 2 mm, 3 mm, 2.5 mm, 1.5 mmor about 1-3 mm. In some embodiments of the device, the slot comprises adistal end that is between two sensors or between two sensels. In someembodiments, the sensor array comprises a slit that substantiallycorresponds in size and shape with the distal end of the slot of thedevice, and the slit terminates at the distal opening of the needleguide. In some embodiments the slit of the sensor array comprises aminimum width along the length of the slit from a first slit wall to asecond slit wall of 0.5 mm to 15 mm, from 0.5 mm to 10 mm, from 0.5 mmto 6 mm, from 0.25 mm to 10 mm, from 0.25 mm to 5 mm, about 1.5 mm,about 2 mm, about 2.5 mm, about 3 mm, 2 mm, 3 mm, 2.5 mm, 1.5 mm orabout 1-3 mm. The position of the slot and or of the slit may bevarious, depending on the embodiment. That is, depending on theembodiment, the slot and slit may be leftward extending from a rightboundary of the sensor array, upward extending from a bottom boundary ofthe sensor array, downward extending from a top boundary of the sensorarray, rightward extending from a left boundary of the sensor array, ordiagonally extending from any boundary of the array that is not onlyleftward extending, rightward extending, upward extending, or downwardextending from a boundary of the sensor array toward the needle guidedistal opening, all of which directions of extension are relative to thesensor array when the array is positioned against a subject and the topboundary is closest to the head of the subject. In some embodiments, thescreen-printed pressure sensor array comprises increased spacing betweenthe upper and lower 5 rows of sensels. In some embodiments, thescreen-printed pressure sensor array comprises a symmetric cutout orsensor array slit in that space. In some embodiments, the cutout or slitin the sensor array is designed for a slot, which accommodates leftwardsliding of the device off the patient. In some embodiments, thescreen-printed pressure sensor array comprises an opening or an orificethrough which a needle is inserted therethrough. In some embodiments,the tactile sensing device does not comprise a slot. For example, incertain embodiments, the tactile sensing device comprises a needle guidethat is reversibly attached to the tactile sensing device, in which casethere is no need for a slot. In some embodiments, the sensor array doesnot comprise a slit.

In some embodiments, the sensor array slit is about 2 mm wide at theslit minimum width from a first slit wall to a second slit wall. In someembodiments, the sensor array slit is about 1 mm wide at the slitminimum width from a first slit wall to a second slit wall. In someembodiments, the sensor array slit is about 0.5 mm wide at the slitminimum width from a first slit wall to a second slit wall. In someembodiments, the sensor array slit is about 3 mm wide at the slitminimum width from a first slit wall to a second slit wall. In someembodiments, the sensor array slit is about 0.1 mm wide at the slitminimum width from a first slit wall to a second slit wall. In someembodiments, the sensor array slit is about 4 mm wide at the slitminimum width from a first slit wall to a second slit wall. In someembodiments, the sensor array slit is about 5 mm wide at the slitminimum width from a first slit wall to a second slit wall. In someembodiments, the sensor array slit is about 6 mm wide at the slitminimum width from a first slit wall to a second slit wall. In someembodiments, the sensor array slit is about 6 mm wide at the slitminimum width from a first slit wall to a second slit wall. In someembodiments, the sensor array slit is about 7 mm wide at the slitminimum width from a first slit wall to a second slit wall. In someembodiments, the sensor array slit is about 8 mm wide at the slitminimum width from a first slit wall to a second slit wall. In someembodiments, the sensor array slit is about 9 mm wide at the slitminimum width from a first slit wall to a second slit wall. In someembodiments, the sensor array slit is about 10 mm wide at the sensorboundary. In some embodiments, the sensor array slit is about 15 mm wideat the sensor boundary. In some embodiments, the sensor array slit isabout 20 mm wide at the sensor boundary. In some embodiments, the sensorarray slit is about 30 mm wide or more at the sensor boundary. In someembodiments, the array slit is a constant width from the distal openingto the sensor array boundary. In some embodiments, the array slit getsnarrower from the sensor array boundary to the distal opening of theneedle guide. In some embodiments, the array slit gets wider from thesensor array boundary to the needle guide distal opening. In someembodiments, the array slit width varies from the sensor array boundaryto the distal opening of the needle guide.

In some embodiments, the sensor array slit is at least about 0.1 mm toabout 30 mm wide at most from a first slit wall to a second slit wall.In some embodiments, the sensor array slit is at least about 0.1 mm toabout 25 mm wide at most from a first slit wall to a second slit wall.In some embodiments, the sensor array slit is at least about 0.1 mm toabout 20 mm wide at most from a first slit wall to a second slit wall.In some embodiments, the sensor array slit is at least about 0.1 mm toabout 15 mm wide at most from a first slit wall to a second slit wall.In some embodiments, the sensor array slit is at least about 0.1 mm toabout 10 mm wide at most from a first slit wall to a second slit wall.In some embodiments, the sensor array slit is at least about 0.1 mm toabout 9 mm wide at most from a first slit wall to a second slit wall. Insome embodiments, the sensor array slit is at least about 0.1 mm toabout 8 mm wide at most from a first slit wall to a second slit wall. Insome embodiments, the sensor array slit is at least about 0.1 mm toabout 7 mm wide at most from a first slit wall to a second slit wall. Insome embodiments, the sensor array slit is at least about 0.1 mm toabout 6 mm wide at most from a first slit wall to a second slit wall. Insome embodiments, the sensor array slit is at least about 0.1 mm toabout 5 mm wide at most from a first slit wall to a second slit wall. Insome embodiments, the sensor array slit is at least about 0.1 mm toabout 4 mm wide at most from a first slit wall to a second slit wall. Insome embodiments, the sensor array slit is at least about 0.1 mm toabout 3 mm wide at most from a first slit wall to a second slit wall. Insome embodiments, the sensor array slit is at least about 0.1 mm toabout 2 mm wide at most from a first slit wall to a second slit wall. Insome embodiments, the sensor array slit is at least about 0.1 mm toabout 1 mm wide at most from a first slit wall to a second slit wall. Insome embodiments, the sensor array slit is at least about 0.1 mm toabout 0.5 mm wide at most from a first slit wall to a second slit wall.

In some embodiments, the screen-printed pressure sensor array detects aplurality of spinous processes in the lumbar region. In someembodiments, the screen-printed pressure sensor array has acenter-to-center (C2C) distance of about 6.86 mm between sensels. Insome embodiments, the screen-printed pressure sensor array has acenter-to-center (C2C) distance of about 6.86 mm between sensels. Insome embodiments, the screen-printed pressure sensor array has acenter-to-center (C2C) distance of about at least 0.5 mm to about 7 mmbetween sensels. In some embodiments, the screen-printed pressure sensorarray has a center-to-center (C2C) distance of about 1 mm betweensensels. In some embodiments, the screen-printed pressure sensor arrayhas a center-to-center (C2C) distance of about 2 mm between sensels. Insome embodiments, the screen-printed pressure sensor array has acenter-to-center (C2C) distance of about 3 mm between sensels. In someembodiments, the screen-printed pressure sensor array has acenter-to-center (C2C) distance of about 4 mm between sensels. In someembodiments, the screen-printed pressure sensor array has acenter-to-center (C2C) distance of about 5 mm between sensels. In someembodiments, the screen-printed pressure sensor array has acenter-to-center (C2C) distance of about 6 mm between sensels. In someembodiments, the screen-printed pressure sensor array has acenter-to-center (C2C) distance of about 7 mm between sensels. In someembodiments, the screen-printed pressure sensor array has acenter-to-center (C2C) distance of about 8 mm between sensels. In someembodiments, the screen-printed pressure sensor array has acenter-to-center (C2C) distance of about 9 mm between sensels. In someembodiments, the screen-printed pressure sensor array has acenter-to-center (C2C) distance of about 10 mm between sensels.

In some embodiments, the screen-printed pressure sensor array has aneffective resolution of about 13.72 mm. In some embodiments, thescreen-printed pressure sensor array has an effective resolution of atleast about 1 mm to at most about 15 mm. In some embodiments, thescreen-printed pressure sensor array has an effective resolution of atleast about 5 mm to at most about 10 mm. In some embodiments, thescreen-printed pressure sensor array has an effective resolution of atleast about 1 mm to at most about 2.5 mm. In some embodiments, thescreen-printed pressure sensor array has an effective resolution ofabout 1 mm. In some embodiments, the screen-printed pressure sensorarray has an effective resolution of about 2 mm. In some embodiments,the screen-printed pressure sensor array has an effective resolution ofabout 3 mm. In some embodiments, the screen-printed pressure sensorarray has an effective resolution of about 4 mm. In some embodiments,the screen-printed pressure sensor array has an effective resolution ofabout 5 mm. In some embodiments, the screen-printed pressure sensorarray has an effective resolution of about 6 mm. In some embodiments,the screen-printed pressure sensor array has an effective resolution ofabout 7 mm. In some embodiments, the screen-printed pressure sensorarray has an effective resolution of about 8 mm. In some embodiments,the screen-printed pressure sensor array has an effective resolution ofabout 9 mm. In some embodiments, the screen-printed pressure sensorarray has an effective resolution of about 10 mm. In some embodiments,the screen-printed pressure sensor array has an effective resolution ofabout 11 mm. In some embodiments, the screen-printed pressure sensorarray has an effective resolution of about 12 mm. In some embodiments,the screen-printed pressure sensor array has an effective resolution ofabout 13 mm. In some embodiments, the screen-printed pressure sensorarray has an effective resolution of about 14 mm. In some embodiments,the screen-printed pressure sensor array has an effective resolution ofabout 15 mm. In some embodiments, the effective resolution of thescreen-printed pressure sensor array is determined by Nyquist criterion.In some embodiments, the effective resolution of the screen-printedpressure sensor array is determined by the total number of sensels inthe sensor array. In some embodiments, the sensitivity of thescreen-printed pressure sensor array is defined by array construction(i.e. related to spacer depth, silver-ink conductivity, and FSRthickness).

In some embodiments, the sensor array visualizes two vertebral gaps. Insome embodiments, the sensor array visualizes the upper- and lower-mostspinous processes (SPs) in the imaged area under the sensor array orwithin range of the sensor array. In some embodiments, the sensor arrayresolves the midline of a spine. In some embodiments, the active areaimaged by the sensor array is rectangular (for example comprising a 50mm×20 mm active area) a polygonal, triangular, circular, or anothershape generally corresponding to the shape of the sensor array shape. Insome embodiments, the screen-printed pressure sensor array visualizesonly two SPs. In some embodiments, height of the screen-printed pressuresensor array is the sum of the height of two SPs (average in addition toone standard deviation) and the interspinous process distance (IPD)(higher-end average in addition to one standard deviation). In someembodiments, the width of the screen-printed pressure sensor array isdefined as the caudal width of an SP (though the cranial width, which issignificantly smaller than the caudal width of an SP, is the moresuperficial feature). In some embodiments, width of the screen-printedpressure sensor array is defined is by the shallowest area between themuscle on either side of the vertebral column. In some embodiments, thecaudal width of an SP is at least about at least 6 mm to about 16 mm atmost. In some embodiments, the cranial width of an SP is at least atleast about 2 mm to about 10 mm at most. In some embodiments, the caudalwidth is about 90% larger than the cranial width. In some embodiments,the caudal width is about 80% larger than the cranial width. In someembodiments, the caudal width is about 70% larger than the cranialwidth. In some embodiments, the caudal width is about 60% larger thanthe cranial width. In some embodiments, the caudal width is about 50%larger than the cranial width. In some embodiments, the caudal width isabout 40% larger than the cranial width. In some embodiments, the widthof the screen-printed pressure sensor array is at least about 6 mm toabout 16 mm at most. In some embodiments, the width of thescreen-printed pressure sensor array is at least about 7 mm to about 16mm at most. In some embodiments, the width of the screen-printedpressure sensor array is at least about 8 mm to about 16 mm at most. Insome embodiments, the width of the screen-printed pressure sensor arrayis at least about 9 mm to about 16 mm at most. In some embodiments, thewidth of the screen-printed pressure sensor array is at least about 10mm to about 16 mm at most. In some embodiments, the width of thescreen-printed pressure sensor array is at least about 11 mm to about 16mm at most. In some embodiments, the width of the screen-printedpressure sensor array is at least about 12 mm to about 16 mm at most. Insome embodiments, the width of the screen-printed pressure sensor arrayis at least about 13 mm to about 16 mm at most. In some embodiments, thewidth of the screen-printed pressure sensor array is at least about 14mm to about 16 mm at most. In some embodiments, the width of thescreen-printed pressure sensor array is at least about 15 mm to about 16mm at most.

In some embodiments, the width of the screen-printed pressure sensorarray is at least about 6 mm. In some embodiments, the width of thescreen-printed pressure sensor array is at least about 7 mm. In someembodiments, the width of the screen-printed pressure sensor array is atleast about 8 mm. In some embodiments, the width of the screen-printedpressure sensor array is at least about 9 mm. In some embodiments, thewidth of the screen-printed pressure sensor array is at least about 10mm. In some embodiments, the width of the screen-printed pressure sensorarray is at least about 11 mm. In some embodiments, the width of thescreen-printed pressure sensor array is at least about 12 mm. In someembodiments, the width of the screen-printed pressure sensor array is atleast about 13 mm. In some embodiments, the width of the screen-printedpressure sensor array is at least about 14 mm. In some embodiments, thewidth of the screen-printed pressure sensor array is at least about 15mm. In some embodiments, the width of the screen-printed pressure sensorarray is at least about 16 mm. In some embodiments, the width of thescreen-printed pressure sensor array is at least about 17 mm. In someembodiments, the width of the screen-printed pressure sensor array is atleast about 18 mm. In some embodiments, the width of the screen-printedpressure sensor array is at least about 19 mm. In some embodiments, thewidth of the screen-printed pressure sensor array is at least about 20mm. In some embodiments, the width of the screen-printed pressure sensorarray is at least about 25 mm.

Multiplexer

In some embodiments, the tactile sensing device further comprises amultiplexer. In some embodiments, there may be more than onemultiplexer. The multiplexer selects voltage output signals from thesensor and forwards the selected voltage output signals into a singleline. In some embodiments, the multiplexer is an analog multiplexer. Insome embodiments, the analog multiplexer is a 16:1 or an 8:1multiplexer. In some embodiments, the analog multiplexer is a frequencydivision multiplexer or a wave division multiplexer. In various furtherembodiments, the multiplexer is a digital multiplexer. In someinstances, the digital multiplexer is a time division multiplexer. Insome embodiments, the time division multiplexer is a synchronous timedivision multiplexer or an asynchronous time division multiplexer. Insome embodiments, the multiplexer is mounted onto a printed circuitboard.

Voltage Divider

In some embodiments, the tactile sensing device further comprises avoltage divider. In some embodiments, the voltage divider is a componentof a pressure sensor such as a resistive force sensor or of an array ofsensors. In some embodiments, there may be more than one voltagedivider. In some embodiments, the pressure sensor array or a sensorthereof which may be a resistive sensor is coupled to a measuringresistor R_(M) in a voltage divider. In some embodiments, the outputvoltage signal from the force-sensitive resistors is read out using avoltage divider. In some embodiments, the output voltage signal read outusing the voltage divider is described by Equation 1 below.

Equation 1: V_(OUT)=(R_(M) V_(IN))/(R_(M)+R_(FSR)); wherein V_(OUT) isthe output voltage signal, R_(M) is the measuring resistor, V_(IN) isthe input voltage signal, and R_(FSR) is the resistance detected by thepressure-sensitive resistor. In some embodiments, the voltage divider isa resistive voltage divider, a low-pass RC filter voltage divider, aninductive voltage divider, or a capacitive voltage divider.

Voltage Source

In some embodiments, the tactile sensing device further comprises avoltage source. In some embodiments, the voltage source is a battery. Insome embodiments, the voltage source is rechargeable. In someembodiments, the voltage source is removable. In some embodiments, thevoltage source includes, but is not limited to: a nickel cadmium (NiCd)battery, nickel-metal hydride (NiMH) battery, a nickel zinc (NiZn)battery, a lead acid battery, a lithium ion battery (Li-ion), or alithium ion polymer (Li-ion polymer) battery.

In some embodiments, the electronic unit 34 comprises the display screen4 and a connector (not shown in FIGS. 1A-B) configured to operativelyconnect the electronic unit 34 to the sensor unit 32. In someembodiments, the display screen 4 is configured to display: a pressuremap 6 representing a target tissue location in an individual in needthereof based upon a first voltage signal and a second voltage signalfrom the sensor array 24, a projected subcutaneous needle location 10 tobe inserted into the individual, and an original skin level needlelocation 8.

Display Screen

In some embodiments, the tactile sensing device 100 comprises a displayscreen 4 to provide visual information to a user. In some embodiments,the display screen 4 is operatively connected to the tactile sensingdevice 100. In some embodiments, the display screen 4 is a computerscreen, a mobile device screen, or a portable device screen. In someembodiments, the display screen 4 is a liquid crystal display (LCD). Infurther embodiments, the display screen 4 is a thin film transistorliquid crystal display (TFT-LCD). In some embodiments, the displayscreen 4 is an organic light emitting diode (OLED) display. In variousfurther embodiments, an OLED display is a passive-matrix OLED (PMOLED)or active-matrix OLED (AMOLED) display. In some embodiments, the displayscreen 4 is a plasma display. In some embodiments, the display screen 4is a video projector. In still further embodiments, the display screen 4is a combination of devices such as those disclosed herein. In someembodiments, the display screen 4 is a full color display. In someembodiments, the display screen 4 is a monochromatic display.

In some embodiments, the visual information provided to the user via adisplay screen 4 is a pressure map 6 representing bone and non-bonestructures. In some embodiments, the pressure map 6 is a heat map. Insome embodiments, the sensor array comprises at least one sensorconfigured to output a signal in response to a change in pressureapplied to its surface, wherein the signal is represented as a heat map6. In some embodiments, the heat map 6 is a graphical representation ofvoltage signals wherein the individual voltage output signals arerepresented as a plurality of colors, color hues, color saturations,graphical patterns, shading, geometrical figures, or any combinationthereof. In some embodiments, high voltage output signals arerepresented in a red-based color and low voltage output signals arerepresented in blue-based color. In some embodiments, high voltages areabout 5V. In some embodiments, high voltages in a heat map correspond toa bone. In some embodiments, high voltages in a heat map correspond tospinous processes. In some embodiments, the heat map displays highvoltages in a red color. In some embodiments, the heat map displays lowvoltages in a blue color. In some embodiments, low voltages in a heatmap correspond to tissue softer than bone. In some embodiments, lowvoltages in a heat map correspond to inter interspinous ligaments.

In some embodiments, the pressure map is overlaid onto a second image.In some embodiments, the second image is a type of diagnostic imageincluding, but not limited to: radiography image, magnetic resonanceimaging (MRI) image, computed tomography (CT) image, nuclear medicineimage, ultrasound image, photoacoustic image, or thermography image. Insome embodiments, the second image is an image of bone and non-bonestructures. In some embodiments, the second image of a bone and non-bonestructure is an image of a rib; an articular surface such as, avertebral articulation, an articulation of a first bone of a hand with asecond bone of the hand, an elbow joint, a wrist joint, an axillaryarticulation of a first bone of a shoulder with a second bone of theshoulder, a sternoclavicular joint, a temporomandibular joint, asacroiliac joint, a hip joint, a knee joint, or an articulations of afirst bone of a foot with a second bone of the foot; non-bone structureis subcutaneous tissue, a muscle, a ligament, adipose tissue, a cyst, ora cavity.

In some embodiments, the pressure map 6 is a heat map. In someembodiments, the pressure map 6 shows the needle position of the needle14 at the skin level (“original”), and its adjusted, projected location,accounting for the depth of the subcutaneous tissue. In someembodiments, the pressure map 6 displays the original skin levellocation of the needle 8. In some embodiments, the pressure map 6displays the projected subcutaneous position of the needle 10, adjustedfor the depth of the subcutaneous tissue. In some embodiments, thepressure map 6 shown in FIG. 1A is generated by using the tactilesensing device on a lumbar spine model. In some embodiments, thepressure map 6 shown in FIG. 1A is generated by using the tactilesensing device on the lumbar region of a patient. In some embodiments,the pressure map 6 shown in FIG. 1A displays two spinous processes(darker areas) and the soft tissue (lighter areas) surrounding thespinous processes. In some embodiments, pressing the tactile sensingdevice 100 against bone, outputs a higher voltage signal compared to thevoltage signal output when pressing the tactile sensing device 100against soft tissue. In some embodiments, the pressure map 6 enables auser to correctly identify and distinguish hard tissue (e.g. bone andbony landmarks) from soft tissue (e.g. adipose tissue, muscle,ligaments, and tendons).

In some embodiments, the original skin level needle location 8 is thelocation at which the needle penetrates the skin of the individual. Insome embodiments, the original skin level needle location 8 is alsotermed the original needle location, the original skin level needlelocation, or the needle entry location. In some embodiments, theoriginal skin level needle location 8 is depicted with a circle. In someembodiments, the projected subcutaneous needle location 10 is depictedwith a cross shape or a star shape or a crosshair display indicator. Insome embodiments, the original skin level needle location 8 and theprojected subcutaneous needle location 10 are labeled with words, suchas “original” and “projected” or “adjusted,” or abbreviations, such as“O” and “P” in order for a user to identify them correctly on thedisplay screen 4. In some embodiments, the original skin level needlelocation (for example, which is indicated by a crosshair displayindicator) stays at the center of the display, and the heat map itselfis translated based on algorithm output (by the same factor thecrosshair would be in an embodiment where the crosshair moves based onthe movement of the sensor array on the subject/patient).

In some embodiments, a trigonometric algorithm, as shown in Equation 2below, is used to determine the projected subcutaneous needle location10 at which the needle will be once it traverses the subcutaneoustissue. Equation 2: h=tan(θ)*d; wherein h is solved for in thisequation, d refers to the tissue depth; and θ is the cephalad angle inradians at which the needle is inserted. FIG. 1A shows representativeX-, Y-, and Z-axes defining an origin at the original skin level needlelocation 8. In some embodiments, h is the distance along the Y-axisbetween the original skin level needle location 8 and the projectedsubcutaneous location of the needle 10. That is, while the features suchas bones are shown are in their correct locations, due to the depth theneedle will have to traverse, it will not hit those features at theangle it's inserted due to adjustment the device provides in angle andinsertion location. Similarly, while the target location is in itscorrect location, due to the depth the needle will traverse, without theadjustment of angle and insertion direction at the skin level that thedevice provides, the needle might otherwise miss its target locationsubcutaneously. In some embodiments, the projected subcutaneous needlelocation 10 is located distally away from the original skin level needlelocation 8. In some embodiments, the original skin level needle location8 has coordinates (x, y, z), as shown in FIG. 1A. In some embodiments,the Z-axis, shown in FIG. 1A, represents the tissue depth at which theneedle is inserted into a patient. In some embodiments, the originalskin level needle location 8 has coordinates (x, y, 0), wherein z=0represents the needle has not penetrated the subcutaneous tissue and isat the level of the skin. In some embodiments, the projectedsubcutaneous needle location 10 has coordinates (x, y+h, z+d), as shownin FIG. 1A. In some embodiments, z+d represents z-coordinate of thepoint in space where the tip of the needle is located once it traversesthe subcutaneous tissue. In some embodiments, d represents the tissuedepth. In some embodiments, 0 is assumed to be the angulation (i.e.cephalad angulation, that is, h*tan (treatment angle)=d; tangent ofcomplementary angles). In some embodiments, 0 is the treatment angledefined as the space between the posterior face of the sensor array andthe needle.

In some embodiments, the (x, y, z) coordinates (x, y+h, z+d) of theprojected subcutaneous location of the needle 10 are displayed on thedisplay screen 4. In some embodiments, the (x,y) coordinates (x, y+h) ofthe projected subcutaneous needle location 10 are displayed on thedisplay screen 4. In some embodiments, the y-coordinate y+h of theprojected subcutaneous needle location 10 are displayed on the displayscreen 4. In some embodiments, the projected subcutaneous needlelocation 10 is displayed two-dimensionally on the display screen 4, asshown in FIGS. 1A and 1B. In some embodiments, the projectedsubcutaneous needle location 10 is displayed two-dimensionally on thedisplay screen 4 by displaying the (x, y) coordinates (x, y+h). In someembodiments, the projected subcutaneous needle location 10 is displayedthree-dimensionally on the display screen 4. In some embodiments, theprojected subcutaneous needle location 10 is displayedthree-dimensionally on the display screen 4 by displaying thecoordinates (x, y+h, z+d). In some embodiments, a 3D representation ofthe needle, terminating at the projected, subcutaneous site, isdisplayed on the display.

In some embodiments, the depth, d, at which the needle will be once ittraverses the subcutaneous tissue (e.g. adipose tissue, muscle,ligaments, and/or tendons) is calculated. In some embodiments, thedepth, d, is calculated based on the signal output of the sensor array.In some embodiments, the depth, d, is calculated based on a voltagesignal ratio, V_(max)/V_(min) produced by the sensor array. In someembodiments, the voltage signal ratio, V_(max)/V_(min) is defined as theratio between a maximum voltage reading, V_(max), (for example, over aspinous process) and a minimum voltage reading (for example, oversubcutaneous tissue). In some embodiments, the voltage signal ratioV_(max)/V_(min) is determined by aligning the sensor array such that theY-axis shown in FIG. 1A vertically traverses the midline of the spinousprocesses (i.e. the Y-axis shown in FIG. 1A represents the midline ofthe spinous processes). In some embodiments, the maximum voltagereading, V_(max), and the minimum voltage reading, V_(min), aredetermined by selecting the maximum and minimum voltage readingsdetected along the midline of the active area subjected to tactilesensing by the sensor array (e.g. along the Y-axis shown in FIG. 1A). Insome embodiments, the voltage signal ratio V_(max)/V_(min) is determinedby using the voltage signal readings located along the midline of apressure map 6 (i.e. along the Y-axis shown in FIG. 1A).

In some embodiments, the depth, d, is calculated based on a firstvoltage signal ratio V_(max1)/V_(min1) and a second voltage signalV_(max2)/V_(min2) produced by the sensor array. In some embodiments, thevoltage signal ratio V_(max1)/V_(min1) is acquired by placing thetactile sensing device (i.e. the sensor array) on the skin surface of apatient. In some embodiments, the second voltage signalV_(max2)/V_(min2) is an empirically determined ratio of the maximumvoltage reading, V_(max2), to the minimum voltage reading, V_(min2). Insome embodiments, the empirically determined second voltage signal ratioV_(max2)/V_(min2) corresponds to a known depth, d. In some embodiments,a plurality of second voltage signal ratios V_(max2)/V_(min2) areempirically obtained using the tactile sensing device and correlated toa known tissue depth. In some embodiments, a plurality of second voltagesignal ratios, V_(max2)/V_(min2), are empirically obtained using thetactile sensing device and correlating the second voltage signal ratiosto a plurality of corresponding tissue depths in a spinal lumbar model.In some embodiments, a plurality of second voltage signal ratios,V_(max2)/V_(min2), are empirically obtained using the tactile sensingdevice and correlating the second voltage signal ratios to a pluralityof corresponding tissue depths in a human cadaver. In some embodiments,the plurality of empirically determined second voltage signal ratios,V_(max2)/V_(min2), and corresponding tissue depths are compiled in atissue depth database. In some embodiments, the tissue depth database isaccessed by the computing device of the tactile sensing system. In someembodiments, the computing device obtains a first voltage signal ratio,V_(max1)/V_(min1), accesses the tissue depth database, compares thefirst voltage signal ratio, V_(max1)/V_(min1) to an empiricallydetermined second voltage signal ratio V_(max2)/V_(min2), obtains thetissue depth corresponding to the second voltage signal ratioV_(max2)/V_(min2) (and consequently, also corresponding to the firstvoltage signal ratio V_(max1)/V_(min1)), and uses the obtained tissuedepth to calculate the subcutaneous projected needle location 10 basedon Equation 2.

In some embodiments, the tissue depth, d, used in Equation 2 (i.e. thelevel at which the needle will be once it traverses the subcutaneoustissue) is calculated based on a machine-learning algorithm. In someembodiments, the machine-learning algorithm is selected from a pluralityof machine-learning algorithms. In some embodiments, themachine-learning algorithm selected to calculate tissue depth, d, usedin Equation 2, is the machine-learning algorithm that outputs the bestapproximation of the tissue depth (i.e. that outputs the least amount oferror). In some embodiments, the machine-learning algorithm learns atarget function (f) that best maps a voltage signal ratioV_(max)/V_(min) to a tissue depth. In some embodiments, themachine-learning algorithm learns a target function (f) that predicts atissue depth based on a voltage signal ratio V_(max)/V_(min). In someembodiments, the machine-learning algorithm includes an irreducibleerror to account for not having sufficient attributes to predict thetissue depth. In some embodiments, the function (f) is linear. In someembodiments, the function (f) is nonlinear.

In some embodiments, the tactile sensing device comprises amachine-learning system. In some embodiments, the machine-learningsystem comprises a machine-learning model, a set of parameters, and alearner. In some embodiments, the machine-learning model makespredictions or approximations of a tissue depth. In some embodiments,the parameters are the input that is used by the model to make itsapproximations. In some embodiments, the parameters are the firstvoltage signal ratio V_(max1)/V_(min1), the second voltage signal ratioV_(max2)/V_(min2), and the known tissue depths (e.g. obtained from humancadavers, patients (e.g. actual outcome), and/or spinal lumbar models).In some embodiments, the learner is the system that adjusts theparameters, and in turn the machine-learning model, by looking atdifferences in the predictions versus actual outcome. In someembodiments, the machine-learning system uses a mathematical equation toexpress the relationship between the second voltage signal ratioV_(max2)/V_(min2) and a known tissue depth. In some embodiments, thefirst voltage signal ratio V_(max1)/V_(min1) is given to themachine-learning system. In some embodiments, the first voltage signalratio V_(max1)/V_(min1) is the training data used by the learner totrain the machine-learning model and improve the predictedapproximations of the tissue depth. In some embodiments, the learnermakes adjustments to the parameters in order to refine themachine-learning model. In some embodiments, the machine-learning modelpredicts a tissue depth by: a) having the machine-learning model receiveinput data or training data (i.e. the first voltage signal ratioV_(max1)/V_(min1)), b) using a mathematical equation to represent thetraining data, c) having the learner compare the training data to themathematical equation; d) having the learner adjust the training data toreshape the machine-learning model (i.e. to adjust the mathematicalequation used by the machine-learning model in step b)), repeating stepsa)-d) until a high degree of confidence is achieved on the predictedtissue depth.

In some embodiments, the machine-learning algorithm enhances theaccuracy of the displayed, projected subcutaneous needle location. Insome embodiments, the visualization of a projected subcutaneous needlelocation helps the user optimally gauge when they have positioned thesensor array at a location that will allow them to accurately andreliably reach the midline of the target tissue location (e.g. thespine) with the needle.

In some embodiments, the sensor unit 32 is disposable. In someembodiments, the sensor unit 32 is reusable. In some embodiments, thesensor unit 32 comprises the needle guide 2. In some embodiments, thesensor unit 32 comprises a sensor array 24. In some embodiments, thesensor array 24 comprises: a first sensor comprising a first surface, asecond sensor comprising a second surface, the first sensor configuredto output a first voltage signal in response to a first change in afirst pressure applied to the first surface, and the second sensorconfigured to output a second voltage signal in response to a secondchange in a second pressure applied to the second surface. In someembodiments, the sensor array 24 is coupled to and positioned directlyunderneath the needle guide 2. In some embodiments, the sensor array 24is a matrix array. In some embodiments, the sensor array 24 is aflexible sensor array. In some embodiments, the sensor array 24 isattached to a sensor array attachment area (not shown in FIGS. 1A-B). Insome embodiments, the sensor array 24 is adhered to the posteriorsurface of the tactile sensing device 100.

In some embodiments, the tactile sensing device 100 comprises a recess124 comprising a first recess wall 126 a and a second recess wall (notshown in FIGS. 1A and 1B). In some embodiments, the first recess wall126 a and the second recess wall are connecting walls. In someembodiments, the first recess wall 126 a and the second recess wall forma first “U” shape. In some embodiments, the needle guide 2 comprises aslot 38. In some embodiments, the needle guide 2 comprises a first slotwall 130 a and a second slot wall (not shown in FIGS. 1A and 1B). Insome embodiments, the first slot wall 130 a and the second slot wall areconnecting. In some embodiments, the first slot wall 130 a and thesecond slot wall form a second “U” shape. In some embodiments, theneedle guide 38 comprises a slot opening 38 a and a slot terminus 38 b.In some embodiments, the needle guide 2 has a proximal opening 134 a anda distal opening 134 b and a track therebetween configured to guide theneedle 14 at a predetermined angle relative to the surfaces of thesensors and/or relative to the face of the sensor array as the needle 14travels into the subject.

In some embodiments, the sensor array (not shown in FIGS. 1A-B) is anarray of sensor elements also known as “sensels.” In some embodiments,the sensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIGS. 1A-B), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIGS. 1A-B) is an array of cells. In someembodiments, the sensor array (not shown in FIGS. 1A-B) is an array ofsensing cells. In some embodiments, the sensor array slit (not shown inFIGS. 1A-B) is positioned between two rows or more of sensels. In someembodiments, the sensor array slit (not shown in FIGS. 1A-B) ispositioned between two columns or more of sensels. In some embodiments,the sensor array slit (not shown in FIGS. 1A-B) is within the bounds ofthe sensor array, and/or within the bounds of the sensor array outeredges, and/or within the edges bounding of the sensor array. In someembodiments, the distal opening 134 b of the needle guide 2 ispositioned between two rows of sensels. In some embodiments, the distalopening 134 b of the needle guide 2 is positioned between two columns ofsensels. In some embodiments the distal opening 134 b of the needleguide 2 is within the bounds of the sensor array, and/or within thebounds of the sensor array outer edges, and/or within the edges boundingof the sensor array. In some embodiments, the distal opening 134 b isbetween two or more sensors of the sensor array. In some embodiments,the distal opening 134 b is positioned between two rows or more ofsensels. In some embodiments, the distal opening 134 b is positionedbetween two columns or more of sensels.

In some embodiments, track is shaped as a “V.” In some embodiments,track is shaped as a “U.” In some embodiments, the track comprises a lipthat protrudes from one of the slot walls (i.e., from the first slotwall 130 a or from the second slot wall (not shown in FIGS. 1A and 1B)).In some embodiments, the lip aligns with an arm of the V or of the Ushape. The track shape and the lip thereof allows the needle to beseated in the track and not slip toward the opening of the slot prior toor during insertion of the needle into the subject.

In some embodiments, the needle guide 2 is flexible. In someembodiments, the needle guide 2 comprises a flexible catch. In someembodiments, the flexible catch comprises a flexible material. In someembodiments, the first slot wall 130 a and the second slot wall 130 bare composed of a soft, flexible material. Non-limiting examples of thesoft, flexible materials include: silicone rubber, natural rubber,acrylonitrile-butadiene rubber, hydrogenated acrylonitrile-butadienerubber, ethylene propylene diene rubber, fluorocarbon rubber,chloroprene rubber, fluorosilicone rubber, polyacrylate rubber, ethyleneacrylic rubber, styrene-butadiene rubber, polyester urethane rubber, orpolyether urethane rubber. In some embodiments, the catch is shaped as adisc with a slit therein that aligns with an axis of the slot thatextends from the terminus to the opening of the slot. In someembodiments, the catch allows for reversible and temporary holding ofthe needle or of the injector device and results in alignment with andseating of the needle in the track such that the needle does not sliptoward the opening of the slot prior to or during the movement of theneedle into the subject.

In some embodiments, the recess 124 has an axis Y2, as shown in FIG. 1A,that extends from the base of the first “U” to between the first recesswall 126 a and the second recess wall. In some embodiments, the slot 38shares the axis Y2 of the recess 124. In some embodiments, the needleguide 2 is located at the apex of the second “U.” In some embodiments,the needle guide 2 is located at the apex of the first “U.” In someembodiments, the recess 124 provides a stop for the needle 14 such thatthe syringe barrel and/or the needle hub have a limited distal distancethat they are advanced along the slot 38. In some embodiments, theneedle 14 rests on the recess 124.

In some embodiments, the pressure sensor connector 12 is located alongaxis Y2. In some embodiments, the pressure sensor connector 12 islocated at an offset relative to axis Y2. In some embodiments, thepressure sensor connector 12 is located distally away from the recess124, between the posterior end of the display screen 4 and the recess124. In some embodiments, the recess 124 comprises the needle guide 2.In some embodiments, the first recess wall 126 a or the second recesswall, or both, comprise a top bevel 128, such that the recess 124 isnarrower closer to the slot 38 than the recess 124 is further from theslot 38. In some embodiments, the tactile sensing device 100 does notcomprise a slot 38. In some embodiments, the needle 14 is inserted inthe recess 124, along the edges of the top bevel 128, when the tactilesensing device 100 does not comprise a slot 38. In some embodiments, thetop bevel 128 is positioned on top of the anterior surface of the sensorarray.

In some embodiments, one or more of the walls of the slot 38 areperpendicular to the track. In some embodiments, the track comprises anotch (not shown in FIGS. 1A-B) or catch configured to reversibly ortemporarily secure the needle in place. In some embodiments, the slot 38is parallel to the track. In some embodiments, one or more of the wallsof the slot 38 parallel to the top bevel 128, as shown in FIG. 1A. Insome embodiments, the slot 38 is enclosed by the first slot wall 130 aand the second slot wall, (the second slot wall is not shown in FIGS.1A-B). In some embodiments, the needle guide 2 is in open connectionwith the slot 38. In some embodiments, the slot 38 comprises a firstslot wall and a second slot wall (not shown in FIGS. 1A-B). In someembodiments, the slot walls are configured to guide a needle 14 towardsthe needle guide 2. In some embodiments, the needle guide 2 is fixed.

In some embodiments, the track 144 is angled at a treatment angleranging between about 40° to about 90° with respect to the posteriorface of the sensor array 24. In some embodiments, the track 144 isangled at a treatment angle ranging between about 69° to about 81° withrespect to the posterior face of the sensor array 24. In someembodiments, the track 144 is angled at a treatment angle rangingbetween about 75° to about 90° with respect to the posterior face of thesensor array 24.

In some embodiments, the top bevel 128 comprises a first needlealignment guide 36 a, a second needle alignment guide 36 b, and a thirdneedle alignment guide 36 c. In some embodiments, the needle alignmentguide 36 is a marking, a notch, an indentation, a sticker, a light, alight bulb, a light emitting diode (LED), or any combination of these,configured to provide the user with an alignment reference tool to alignthe needle along a proper axis or in a proper location that is adequatefor needle insertion into an individual along the track. In someembodiments, the needle alignment guide 36 is a visual cue for midlinealignment. In some embodiments, the needle alignment guide 36 is amechanical feature (e.g., a notch) in the area located along an edge ofthe needle guide 2 and/or slot 38. In some embodiments, the framecomprises a needle alignment guide. In some embodiments, the needlealignment guide is a notch or a marking on the surface of the tactilesensing device. In some embodiments, the needle alignment guide 36alerts the user when the needle is or is not in a proper or correctalignment or position. For instance, in one embodiment, the needlealignment guide 36 is an LED that turns on and emits a green light whenthe needle is aligned properly or in the correct position for insertion.For instance, in some embodiments, the needle alignment guide 36 is anLED that turns on and emits a red light when the needle is alignedimproperly or is not in the correct position for insertion. In someembodiments, the needle alignment guide 36 is an LED that only turns onwhen the needle is aligned properly or in the correct position forinsertion. In some embodiments, the needle alignment guide 36 is an LEDthat only turns on when the needle is not aligned properly or is not inthe correct position for insertion.

FIGS. 2A and 2B show an illustration of an embodiment of the tactilesensing device 200. In some embodiments, the tactile sensing device 200comprises a sensor array (not shown in FIGS. 2A-B), a display screen 4,a needle guide 2, and a pressure sensor connector 12. In someembodiments, the display screen 4 comprises pressure map features, suchas a simple centerline, or a plurality of active lines, which connectdetected peaks and offer a visual indication of alignment (e.g. flashingor an once it's within 5° of the centerline). In some embodiments, thepressure map 6 displayed on the display screen 4 comprises visual cuessuch as crosshairs 30, as shown in FIG. 2A. In some embodiments, thecrosshairs 30 provide the user with a visual indication of midlinealignment (i.e. alignment both along longitudinal and lateral axes onthe display screen 4). In some embodiments, the tactile sensing device200 provides visual, auditory, and/or haptic cues to indicate to a userwhen the tactile sensing device 200 and/or the needle are aligned or notaligned with the target tissue location.

In some embodiments, the tactile sensing device 200 comprises a needleguide 2. In some embodiments, the needle guide 2 comprises a proximalopening 134 a and a distal opening 134 b. In some embodiments, a track144 is in between the proximal opening 134 a and the distal opening 134b. In some embodiments, the track 144 is configured to guide a needleinto a target tissue location at a predetermined treatment angle. FIGS.2A-B show the tactile sensing device 200 comprising a slot 38. In someembodiments, the slot 38 is perpendicular to the needle guide 2, asshown in FIG. 2A. FIG. 2A shows the tactile sensing device 200comprising a recess 124. In some embodiments, the recess 124 comprises apressure sensor connector 12. In some embodiments, the recess 124 endson a second slot wall (not shown in FIGS. 2A-B).

FIG. 2B shows a user 28 resting a needle 14 on notch 132 and on thetrack 144 (not shown in FIG. 2B, but shown in FIG. 2A). In someembodiments, the notch 132 reversibly secures the needle onto the track144. In some embodiments, the notch 132 reversibly secures the needle inplace. In some embodiments, the notch 132 aligns the needle at a correctangle aligned with the angle of the track. In some embodiments, thenotch 132 aligns the needle with a target tissue location. In someembodiments, the notch 132 comprises a lip that interrupts and protrudesfrom one or more slot wall and temporarily and reversibly reduces thechance of or prevents the needle from moving off the track 144. In someembodiments, the notch 132 prevents the needle from being inserted offcenter into the target tissue location. In some embodiments, the needle14 rides over and/or along the notch (not shown in FIGS. 2A-B).

In some embodiments, the notch 132 is or comprises a lip. In someembodiments, the notch 132 comprises a rubber or plastic lip that mustbe overcome by the needle in order to move the needle 14 along the track144 and toward the distal opening 134 b. In some embodiments, the lip isshaped as a “U” and comprises an opening. In some embodiments, the lipis flexible. In some embodiments, the lip is rigid. In some embodiments,the opening of the lip is narrower than the proximal opening 134 a inorder to prevent a needle 14 from moving off the track 144 once insertedthrough the notch 132. In some embodiments, the notch 132 comprises morethan one lips or rings positioned along the track 144. In someembodiments, the notch 132 comprises at least two lips or ringspositioned along the track 144. In some embodiments, the notch 132comprises at least three lips or rings positioned along the track 144.In some embodiments, the notch 132 comprises at least four lips or ringspositioned along the track 144. In some embodiments, the notch 132comprises at least five lips or rings positioned along the track 144. Insome embodiments, the notch 132 comprises at least ten lips or ringspositioned along the track 144.

In some embodiments, the notch 132 comprises a groove. In someembodiments, the groove has a “U” shaped form and has a first lateralwall and a second lateral wall that have both extremities (or arms)open. In some embodiments, one pair of projections are located in thefirst lateral wall and in the second lateral wall, opposite from oneanother and with a profile that defines the continuation of the curvedwall of each groove, in a way that accommodates the cylindrical cannulaof the needle 14. In some embodiments, the user inserts the needle 14into the groove by pushing the needle into the groove, with a lightforce so that the body of the needle overcomes the projections of thegroove. In some embodiments, the user releases the needle 14, by pullingon its proximal extremity, with a light force so that the body of theneedle passes the projections of the groove. In some embodiments,alternatively, the user releases the needle 14, by sliding the needle 14along the track 144, towards the proximal opening 134 a. In someembodiments, the groove is composed of a soft, flexible material inorder to enable separation of the extremities of the “U” when the needle14 is either inserted or released.

In some embodiments, the notch 132 comprises a beveled edge. In someembodiments, the beveled edge must be overcome in order to move theneedle 14 along the track 144 and toward the distal opening 134 b. Insome embodiments, the notch 132 comprises more than beveled edgespositioned along the track 144. In some embodiments, the beveled edge ispositioned at the proximal opening 134 a. In some embodiments, thebeveled edge is positioned at the distal opening 134 b.

In some embodiments, the notch 132 comprises a bump. In someembodiments, the bump is positioned at the proximal opening 134 a. Insome embodiments, the bump is positioned at the distal opening 134 b. Insome embodiments, the bump is composed of a soft, flexible material suchas, but not limited to rubber or silicone. In some embodiments, the bumpis shaped as a “U.” In some embodiments, the bump is shaped as a “V.” Insome embodiments, the bump mates with the notch 132. In someembodiments, the bump interrupts the wall of the slot or protrudes fromthe wall of the slot.

In some embodiments, the notch 132 is a plastic piece. In someembodiments, the notch 132 is a rubber piece. In some embodiments, thenotch 132 is a stopper notch. In some embodiments, the notch 132 is agrip.

In some embodiments, the notch 132 is a snap-on notch. In someembodiments, the user snaps the needle into the snap-on notch to securethe needle in the track 144. In some embodiments, the snap-on notch hasa “U” shaped form and has a first lateral wall and a second lateral wallthat have both ends open. In some embodiments, one pair of projectionsare located in the first lateral wall and in the second lateral wall,opposite from one another and with a profile that defines thecontinuation of the curved wall of each snap-on notch, in a way thatperfectly accommodates the cylindrical cannula of the needle 14. In someembodiments, the user inserts the needle 14 into the snap-on notch bypushing the needle into the snap-on notch, with a light force so thatthe cannula of the needle overcomes the projections of the snap-onnotch. In some embodiments, the user releases the needle 14, by pullingon its proximal end, with a light force so that the body of the needlepasses the projections of the snap-on notch. In some embodiments,alternatively, the user releases the needle 14, by sliding the needle 14along the track 144, towards the proximal opening 134 a. In someembodiments, the snap-on notch is composed of a soft, flexible materialin order to enable separation of the ends of the “U” when the needle 14is either inserted or released. In some embodiments, the snap-on notchis composed of a rigid material.

In some embodiments, the notch 132 comprises a magnet located at theproximal opening 134 a. In some embodiments, the notch 132 comprises amagnet located at the distal opening 134 b. In some embodiments, thenotch 132 comprises a magnet located along the track 144. In someembodiments, the notch 132 comprises a magnet located along the trackand shaped as a “U.” In some embodiments, the notch 132 comprises amagnet located along the track and shaped as a cylinder. In someembodiments, the needle 14 comprises a magnet. In some embodiments, theneedle 14 comprises a magnet located on the needle hub. In someembodiments, the needle 14 comprises a magnet that is coaxially alignedwith the needle cannula. In some embodiments, the needle 14 comprises amagnet located on the tip of the needle 14. In some embodiments, themagnet on the notch 132 defines a magnetic axis that is aligned in adesired predetermined orientation with respect to the needle. In someembodiments, the magnet on the needle 14 defines a magnetic axis that isaligned in a desired predetermined orientation with respect to the notch132. In some embodiments, the desired predetermined orientation is thedesired treatment angle. In some embodiments, the magnet on the notch132 attracts the magnet on the needle 14 and secures the needle onto thetrack 144. In some embodiments, the position of the needle 14 is trackedby tracking the magnet on the notch 132 and by tracking the magnet onthe needle 14. In some embodiments, the tactile sensing system comprisesa magnetic tracking system to track the position of a needle in realtime.

In some embodiments, the sensor array (not shown in FIGS. 2A-B) is anarray of sensor elements also known as “sensels.” In some embodiments,the sensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIGS. 2A-B), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIGS. 2A-B) is an array of cells. In someembodiments, the sensor array (not shown in FIGS. 2A-B) is an array ofsensing cells. In some embodiments, the sensor array slit (not shown inFIGS. 2A-B) is positioned between two rows or more of sensels. In someembodiments, the sensor array slit (not shown in FIGS. 2A-B) ispositioned between two columns or more of sensels. In some embodiments,the sensor array slit (not shown in FIGS. 2A-B) is within the bounds ofthe sensor array, and/or within the bounds of the sensor array outeredges, and/or within the edges bounding of the sensor array. In someembodiments, the distal opening 134 b of the needle guide 2 ispositioned between two rows of sensels. In some embodiments, the distalopening 134 b of the needle guide 2 is positioned between two columns ofsensels. In some embodiments the distal opening 134 b of the needleguide 2 is within the bounds of the sensor array, and/or within thebounds of the sensor array outer edges, and/or within the edges boundingof the sensor array. In some embodiments, the distal opening 34 b isbetween two or more sensors of the sensor array. In some embodiments,the distal opening 34 b is positioned between two rows or more ofsensels. In some embodiments, the distal opening 34 b is positionedbetween two columns or more of sensels.

Tactile Sensing Device Methods

Disclosed herein, in certain embodiments, are methods of positioning aneedle in the tactile sensing device, comprising: inserting the needlethrough the slot; guiding the needle in the slot by sliding the needlein between the first slot wall and the second slot wall towards theneedle guide, wherein a first needle guide wall connects to the secondneedle guide wall at the proximal opening of the needle guide to form anotch at the proximal opening; securing the needle in place by insertingthe needle into the notch; and sliding the needle along the track thatextends from the notch at the proximal opening to the distal opening ofthe needle guide.

Spinal Puncture Methods

In some embodiments, methods for performing a spinal puncture in anindividual in need thereof, comprise: placing a tactile sensing deviceon a lumbar region of the individual; applying force to the tactilesensing device against the lumbar region; viewing voltage signals,corresponding to vertebral articulations, detected by the tactilesensing device resulting from the application of force to the tactilesensing device against the lumbar region, on a display screen;localizing two spinous processes on the image; identifying a gap betweena first spinous process and a second spinous process of the individual;using a needle guide to insert a needle between the first and secondspinous processes of the individual and into a subarachnoid space; andcollecting cerebrospinal fluid or administering a therapeutic agent. Insome embodiments, the method comprises use of an operatively connectedpressure sensor for fluid-pressure measurement.

Epidural Methods

In some embodiments, methods for administering a therapeutic agent to anepidural space of an individual in need thereof, comprise: placing atactile sensing device on a lumbar region of the individual; applyingforce to the tactile sensing device against the lumbar region; viewingvoltage signals, corresponding to vertebral articulations, detected bythe tactile sensing device resulting from the application of force tothe tactile sensing device against the lumbar region, on a displayscreen; localizing two spinous processes on the image; identifying a gapbetween a first spinous process and a second spinous process of theindividual; using a needle guide to insert a needle between the firstand second spinous processes and into the epidural space of theindividual; and injecting a therapeutic agent into the epidural space.In some embodiments, this method comprises attachment of aloss-of-resistance syringe to facilitate detection of epidural-spaceentry.

Therapeutic Agents

In some embodiments, therapeutic agents are delivered via a spinalpuncture. In some embodiments, therapeutic agents delivered via a spinalpuncture include but are not limited to: anesthetics, analgesics,chemotherapeutic agents, contrast agents or dyes, anti-spasmodic agents,antibiotics, or proteins. In some embodiments, anesthetics delivered viaa spinal puncture include but are not limited to: bupivacaine,lidocaine, tetracaine, procaine, ropivacaine, levobupivacaine,prilocaine, and cinchocaine. In some embodiments, analgesics deliveredvia a spinal puncture include but are not limited to: opioids such asmorphine, fentanyl, diamorphine, buprenorphine, and pethidine ormeperidine; and non-opioids such as clonidine. In some embodiments,chemotherapeutic agents delivered via a spinal puncture include but arenot limited to: methotrexate, cytarabine, hydrocortisone, and thiotepa.In some embodiments, contrast agents or dyes delivered via a spinalpuncture include but are not limited to: iohexol, metrizamide,iopamidol, ioversol, iopromide, iodixanol, iolotran, andiodophenylundecylic acid. In some embodiments, anti-spasmodic agentsdelivered via a spinal puncture include baclofen. In some embodiments,antibiotics delivered via a spinal puncture include gentamicin sulphate.In some embodiments, proteins delivered via a spinal puncture includeidursulfase.

Spinous Processes

In some embodiments, methods for performing a spinal puncture in anindividual in need thereof comprise using a needle guide to insert aneedle between the first and second spinous processes and into thesubarachnoid space of the individual. In some embodiments, methods foradministering a therapeutic agent to an epidural space of an individualin need thereof comprise using a needle guide to insert a needle betweenthe first and second spinous processes and into the epidural space ofthe individual. In some embodiments, the first spinous process is a partof the first lumbar vertebra (L1), L2, L3, or L4 lumbar vertebrae andthe second spinous process is a part of L2, L3, L4, or L5 lumbarvertebrae. In some further embodiments, the first and spinous process isa part

In some embodiments, a kit for performing a diagnostic spinal puncturein an individual in need thereof, comprises: a tactile sensing device toimage bone and non-bone structures in the individual; a computer toprocess voltage signals detected by the tactile sensing device; adisplay screen to visualize the bone and non-bone structures; anelectronic pressure sensor to measure cerebrospinal fluid pressure; anda sleeve.

In some embodiments, the slot 38 is the entry point or entrance for theneedle 14. In some embodiments, the user first inserts the needle 14through the slot opening 38 a. In some embodiments, the user guides theneedle 14 in the slot 38 towards the slot terminus 38 b, by sliding theneedle 14 in between the first slot wall 142 a and the second slot wall(not shown in FIGS. 2A-B). In some embodiments, the user guides theneedle 14 in the slot 38 t towards the needle guide 2. In someembodiments, the needle guide 2 comprises a first needle guide wall anda second needle guide wall (not shown in FIGS. 2A-B). In someembodiments, the first needle guide wall connects to the second needleguide wall. In some embodiments, the user contacts the needle 14 withthe first needle guide wall and the second needle guide wall. In someembodiments, the user secures the needle 14 in place by inserting theneedle 14 into the notch 32 located in between the first needle guidewall and the second needle guide wall. In some embodiments, the userslides the needle 14 along the track 144 towards the distal opening ofthe needle guide, in order to insert the needle into a target tissuelocation of an individual.

In some embodiments, the tactile sensing device 200 comprises anindentation in the frame 20. In some embodiments, the indentation isconfigured to act as a grip for a user. FIG. 2B demonstrates user 28utilizing the indentation 42 to hold the tactile sensing device 200. Insome embodiments, the tactile sensing device 200 comprises a sensor unit32 and an electronic unit 34. In some embodiments, the sensor unit 32and the electronic unit 34 are operatively coupled to each other. Insome embodiments, the sensor unit 32 and the electronic unit 34 arenon-reversibly, operatively coupled to each other. In some embodiments,the sensor unit 32 and the electronic unit 34 are reversibly,operatively coupled to each other. In some embodiments, the tactilesensing device 200 comprises a tab (not shown in FIGS. 2A-B) on one ormore lateral sides of the sensor unit 32 configured to release theelectronic unit 34 from the sensor unit 32, once it is depressed by auser. In some embodiments, the tactile sensing device 200 comprises oneor more tabs configured to be pinched, depressed, or pushed by a user inorder to detach the electronic unit 34 from the sensor unit 32. In someembodiments, the sensor unit 32 and the electronic unit 34 arereversibly, operatively coupled to each other via a mechanism thatincludes an audible indication, such as, but not limited to, a clickingnoise, a recording, and/or a ding sound, that indicates when the sensorunit 32 and the electronic unit 34 are attached or detached by a user.

FIG. 3 shows an embodiment of the tactile sensing device 300. In someembodiments, the tactile sensing device 300 comprises a wide cutout 46that enables the user to access the needle guide 2. In some embodiments,the wide cutout 46 enables the user to remove the tactile sensing device300 by sliding the device laterally away from the needle, once theneedle has been inserted into an individual.

In some embodiments, the tactile sensing device 300 comprises a displayscreen 4 located laterally from the needle guide 4, as shown in FIG. 3.In some embodiments, the tactile sensing device 300 comprises a displayscreen 4 located laterally from the needle alignment guide 36, as shownin FIG. 3. In some embodiments, the display screen 4 is a monochromaticscreen. In some embodiments, the display screen 4 is a monochromaticOLED screen. In some embodiments, the display screen 4 comprises a realtime, on-screen targeting 40. In some embodiments, the on-screentargeting 40 provides the user with a visual cue that shows the positionof the needle in real time, as the user moves and adjusts the tactilesensing device 300 to a desired location. In some embodiments, theon-screen targeting 40 identifies the target tissue location and alertsthe user via an auditory, visual, or haptic cue. In some embodiments,the on-screen targeting 40 identifies the midpoint between two spinousprocesses where a needle is to be inserted in order to access theepidural or the subarachnoid space.

In some embodiments, the pressure sensor connector 12 is positioned atan offset relative to the Y-axis shown in FIG. 3. In some embodiments,tactile sensing device 300 comprises an electronic unit 34 comprisingthe display screen 4 and the pressure sensor connector 12. In someembodiments, the electronic unit 34 is elevated and forms a C-grip wherethe user 28 is able to grip the device, as shown in FIG. 3. In someembodiments, tactile sensing device 300 comprises a sensor unit 32. Insome embodiments, the sensor unit 32 acts as a mounting platform,wherein the sensor unit 32 receives the electronic unit 34. In someembodiments, the electronic unit 34 is non-reversibly mounted on top ofthe sensor unit 32. In some embodiments, the electronic unit 34 isreversibly mounted on top of the sensor unit 32. In some embodiments,the sensor unit 32 is disposable. In some embodiments, the sensor unit32 comprises a bifurcated sensor array (not shown in FIG. 3). In someembodiments, the sensor unit 32 comprises a disposable sensor array.

In some embodiments, the tactile sensing device 300 comprises a needleguide platform 136 further comprising a lateral side needle guideplatform wall (not shown in FIG. 3) and an anterior side needle guideplatform wall 140. In some embodiments, the needle guide platform 136elevates the needle guide 2. In some embodiments, the needle guide 2 isfixed. In some embodiments, the needle guide 2 is adjustable and a useris able to manually or automatically adjust the height and angle of theneedle guide 2. In some embodiments, the slot of the needle guide 2comprises a first slot wall 130 a and a second slot wall 130 b thatconnect with each other. In some embodiments, the first slot wall 130 aconnects to the second slot wall 130 b to form the slot. In someembodiments, the slot has an opening and a terminus. In someembodiments, the proximal opening 134 a is at the terminus of the sloton the side of the device not having the sensors thereon. In someembodiments, the needle guide 2 comprises a track 144. In someembodiments, the track 144 is positioned in between a proximal opening134 a and a distal opening 134 b of the needle guide 2. In someembodiments, the needle guide 2 comprises a notch 132 positioned on theproximal opening 134 a of the needle guide. In some embodiments, thenotch 132 is directly aligned with the anterior side needle guideplatform wall 140.

In some embodiments, notch 132 is at least about 1 mm to about 5 mm atmost wide. In some embodiments, notch 132 is about 1 mm wide. In someembodiments, notch 132 is about 2 mm wide. In some embodiments, notch132 is about 3 mm wide. In some embodiments, notch 132 is about 4 mmwide. In some embodiments, notch 132 is about 5 mm wide. In someembodiments, notch 132 is at least about 1 mm to about 5 mm at mostwide. In some embodiments, notch 132 is about 6 mm wide. In someembodiments, notch 132 is about 7 mm wide. In some embodiments, notch132 is about 8 mm wide. In some embodiments, notch 132 is about 9 mmwide. In some embodiments, notch 132 is about 10 mm wide. In someembodiments, notch 132 is at least about 6 mm to about 15 mm at mostwide. In some embodiments, notch 132 is wider than notch 132. In someembodiments, notch 132 is 90% wider than notch 132. In some embodiments,notch 132 is 80% wider than notch 132. In some embodiments, notch 132 is70% wider than notch 132. In some embodiments, notch 132 is 60% widerthan notch 132. In some embodiments, notch 132 is 50% wider than notch132. In some embodiments, notch 132 is 40% wider than notch 132. In someembodiments, notch 132 is 30% wider than notch 132. In some embodiments,notch 132 is 20% wider than notch 132. In some embodiments, notch 132 is10% wider than notch 132.

In some embodiments, notch 132 is shaped as a wide “V.” In someembodiments, notch 132 is shaped as a wide “U.” In some embodiments, thenotch comprises a lip that protrudes from one of the slot walls 130 a or130 b, and in some embodiments aligns with an arm of the V or of the Ushape. The notch and the lip thereof allow the needle to be seated inthe track and not slip toward the opening of the slot prior to or duringinsertion of the needle into the subject.

In some embodiments, the tactile sensing device 300 comprises a needlealignment guide 36. In some embodiments, the needle alignment guide 36is a notch traversing the center of the tactile sensing device 300through a longitudinal axis that is parallel to the track 144, as shownin FIG. 3.

In some embodiments, the sensor array (not shown in FIG. 3) is an arrayof sensor elements also known as “sensels.” In some embodiments, thesensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIG. 3), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIG. 3) is an array of cells. In someembodiments, the sensor array (not shown in FIG. 3) is an array ofsensing cells. In some embodiments, the sensor array slit (not shown inFIG. 3) is positioned between two rows or more of sensels. In someembodiments, the sensor array slit (not shown in FIG. 3) is positionedbetween two columns or more of sensels. In some embodiments, the sensorarray slit (not shown in FIG. 3) is within the bounds of the sensorarray, and/or within the bounds of the sensor array outer edges, and/orwithin the edges bounding of the sensor array. In some embodiments, thedistal opening 134 b of the needle guide 2 is positioned between tworows of sensels. In some embodiments, the distal opening 134 b of theneedle guide 2 is positioned between two columns of sensels. In someembodiments the distal opening 134 b of the needle guide 2 is within thebounds of the sensor array, and/or within the bounds of the sensor arrayouter edges, and/or within the edges bounding of the sensor array. Insome embodiments, the distal opening 34 b is between two or more sensorsof the sensor array. In some embodiments, the distal opening 34 b ispositioned between two rows or more of sensels. In some embodiments, thedistal opening 34 b is positioned between two columns or more ofsensels.

In some embodiments, the tactile sensing device comprises a displayscreen 4 that is adjacent to the needle guide 2, as shown in FIG. 3. Insome embodiments, the display screen 4 is adjacent to the track 144. Insome embodiments, the tactile sensing device comprises a display screen4 that is laterally offset from the midline of the tactile sensingdevice. In some embodiments, the display screen 4 is adjacent to theneedle alignment guide 36. In some embodiments, the display screen 4comprises on-screen targeting 44. In some embodiments, the on-screentargeting 44 is one or more axes (e.g., an x-axis and a y-axis) thatappear on the display screen 4 and help the user to align the tactilesensing device with the target tissue location, an insertion site of theneedle, and/or a projected subcutaneous location of a needle. In someembodiments, the on-screen targeting 44 is a software tool that helpsthe user with alignment of the needle and/or the tactile sensing device.In some embodiments, the on-screen targeting 44 comprises crosshairs, asshown in FIG. 3. In some embodiments, the on-screen targeting 44responds in real time to any movement of the needle and/or the tactilesensing device carried out by the user. For example, in someembodiments, the crosshairs displayed on the display screen 4 moves onthe display screen 4 as the user adjusts the position of the tactilesensing device. In some embodiments, the on-screen targeting 44indicates the proximity of the crosshairs (and/or the target circle atthe center of the crosshairs) to the calculated needle insertion point.In some embodiments, the on-screen targeting 44 uses a light, a sound(e.g., a beeping sound), a visual cue (e.g., blinking of the crosshairson the display screen), or any other suitable indicator to inform theuser of an accurate alignment between the insertion device (e.g., theneedle guide) and the calculated needle insertion point.

FIGS. 4A-B show a high-level concept configuration of the tactilesensing device 400. FIG. 4A shows a front view of the tactile sensingdevice 400. In some embodiments, the tactile sensing device 400comprises a frame 20 that comprises a display screen 4 and a needleguide 2. In some embodiments, the needle guide 2 comprises a slot 38. Insome embodiments, the slot 38 comprises a lateral entrance area (i.e.,the slot opening 38 a) and a medial area (i.e. the slot terminus 38 b).In some embodiments, the slot terminus 38 b is in open connection withthe needle guide 2. In some embodiments, the needle guide 2 is a fixedneedle guide. In some embodiments, the display screen 4 is angled withrespect to the skin surface of the patient. In some embodiments, thedisplay screen is flat. In some embodiments, the angle of the displayscreen 4 is adjustable. In some embodiments, the tactile sensing devicecomprises one or more hinges at the junction of the sensor unit 32 andthe electronic unit 34, which allows the user to adjust the angle of thedisplay screen.

In some embodiments, the tactile sensing device 400 has a length 49 ofabout 198 millimeters (mm). In some embodiments, the tactile sensingdevice 400 has a length 49 of about 150 mm to about 300 mm. In someembodiments, the tactile sensing device 400 has a length 49 of at leastabout 150 mm. In some embodiments, the tactile sensing device 400 has alength 49 of at most about 300 mm. In some embodiments, the tactilesensing device 400 has a length 49 of about 150 mm to about 160 mm,about 150 mm to about 170 mm, about 150 mm to about 180 mm, about 150 mmto about 190 mm, about 150 mm to about 200 mm, about 150 mm to about 210mm, about 150 mm to about 220 mm, about 150 mm to about 230 mm, about150 mm to about 240 mm, about 150 mm to about 250 mm, about 150 mm toabout 300 mm, about 160 mm to about 170 mm, about 160 mm to about 180mm, about 160 mm to about 190 mm, about 160 mm to about 200 mm, about160 mm to about 210 mm, about 160 mm to about 220 mm, about 160 mm toabout 230 mm, about 160 mm to about 240 mm, about 160 mm to about 250mm, about 160 mm to about 300 mm, about 170 mm to about 180 mm, about170 mm to about 190 mm, about 170 mm to about 200 mm, about 170 mm toabout 210 mm, about 170 mm to about 220 mm, about 170 mm to about 230mm, about 170 mm to about 240 mm, about 170 mm to about 250 mm, about170 mm to about 300 mm, about 180 mm to about 190 mm, about 180 mm toabout 200 mm, about 180 mm to about 210 mm, about 180 mm to about 220mm, about 180 mm to about 230 mm, about 180 mm to about 240 mm, about180 mm to about 250 mm, about 180 mm to about 300 mm, about 190 mm toabout 200 mm, about 190 mm to about 210 mm, about 190 mm to about 220mm, about 190 mm to about 230 mm, about 190 mm to about 240 mm, about190 mm to about 250 mm, about 190 mm to about 300 mm, about 200 mm toabout 210 mm, about 200 mm to about 220 mm, about 200 mm to about 230mm, about 200 mm to about 240 mm, about 200 mm to about 250 mm, about200 mm to about 300 mm, about 210 mm to about 220 mm, about 210 mm toabout 230 mm, about 210 mm to about 240 mm, about 210 mm to about 250mm, about 210 mm to about 300 mm, about 220 mm to about 230 mm, about220 mm to about 240 mm, about 220 mm to about 250 mm, about 220 mm toabout 300 mm, about 230 mm to about 240 mm, about 230 mm to about 250mm, about 230 mm to about 300 mm, about 240 mm to about 250 mm, about240 mm to about 300 mm, or about 250 mm to about 300 mm. In someembodiments, the tactile sensing device 400 has a length 49 of about 150mm, about 160 mm, about 170 mm, about 180 mm, about 190 mm, about 200mm, about 210 mm, about 220 mm, about 230 mm, about 240 mm, about 250mm, or about 300 mm.

In some embodiments, the tactile sensing device 400 has a width 51 ofabout 78 mm. In some embodiments, the tactile sensing device 400 has awidth 51 of about 50 mm to about 200 mm. In some embodiments, thetactile sensing device 400 has a width 51 of at least about 50 mm. Insome embodiments, the tactile sensing device 400 has a width 51 of atmost about 200 mm. In some embodiments, the tactile sensing device 400has a width 51 of about 50 mm to about 60 mm, about 50 mm to about 70mm, about 50 mm to about 80 mm, about 50 mm to about 90 mm, about 50 mmto about 100 mm, about 50 mm to about 110 mm, about 50 mm to about 120mm, about 50 mm to about 130 mm, about 50 mm to about 140 mm, about 50mm to about 150 mm, about 50 mm to about 200 mm, about 60 mm to about 70mm, about 60 mm to about 80 mm, about 60 mm to about 90 mm, about 60 mmto about 100 mm, about 60 mm to about 110 mm, about 60 mm to about 120mm, about 60 mm to about 130 mm, about 60 mm to about 140 mm, about 60mm to about 150 mm, about 60 mm to about 200 mm, about 70 mm to about 80mm, about 70 mm to about 90 mm, about 70 mm to about 100 mm, about 70 mmto about 110 mm, about 70 mm to about 120 mm, about 70 mm to about 130mm, about 70 mm to about 140 mm, about 70 mm to about 150 mm, about 70mm to about 200 mm, about 80 mm to about 90 mm, about 80 mm to about 100mm, about 80 mm to about 110 mm, about 80 mm to about 120 mm, about 80mm to about 130 mm, about 80 mm to about 140 mm, about 80 mm to about150 mm, about 80 mm to about 200 mm, about 90 mm to about 100 mm, about90 mm to about 110 mm, about 90 mm to about 120 mm, about 90 mm to about130 mm, about 90 mm to about 140 mm, about 90 mm to about 150 mm, about90 mm to about 200 mm, about 100 mm to about 110 mm, about 100 mm toabout 120 mm, about 100 mm to about 130 mm, about 100 mm to about 140mm, about 100 mm to about 150 mm, about 100 mm to about 200 mm, about110 mm to about 120 mm, about 110 mm to about 130 mm, about 110 mm toabout 140 mm, about 110 mm to about 150 mm, about 110 mm to about 200mm, about 120 mm to about 130 mm, about 120 mm to about 140 mm, about120 mm to about 150 mm, about 120 mm to about 200 mm, about 130 mm toabout 140 mm, about 130 mm to about 150 mm, about 130 mm to about 200mm, about 140 mm to about 150 mm, about 140 mm to about 200 mm, or about150 mm to about 200 mm. In some embodiments, the tactile sensing device400 has a width 51 of about 50 mm, about 60 mm, about 70 mm, about 80mm, about 90 mm, about 100 mm, about 110 mm, about 120 mm, about 130 mm,about 140 mm, about 150 mm, or about 200 mm.

In some embodiments, the display screen 4 has a display screen length 53of about 99 mm. In some embodiments, the display screen 4 has a displayscreen length 53 of about 40 mm to about 150 mm. In some embodiments,the display screen 4 has a display screen length 53 of at least about 40mm. In some embodiments, the display screen 4 has a display screenlength 53 of at most about 150 mm. In some embodiments, the displayscreen 4 has a display screen length 53 of about 40 mm to about 50 mm,about 40 mm to about 60 mm, about 40 mm to about 70 mm, about 40 mm toabout 90 mm, about 40 mm to about 100 mm, about 40 mm to about 110 mm,about 40 mm to about 120 mm, about 40 mm to about 130 mm, about 40 mm toabout 140 mm, about 40 mm to about 150 mm, about 50 mm to about 60 mm,about 50 mm to about 70 mm, about 50 mm to about 90 mm, about 50 mm toabout 100 mm, about 50 mm to about 110 mm, about 50 mm to about 120 mm,about 50 mm to about 130 mm, about 50 mm to about 140 mm, about 50 mm toabout 150 mm, about 60 mm to about 70 mm, about 60 mm to about 90 mm,about 60 mm to about 100 mm, about 60 mm to about 110 mm, about 60 mm toabout 120 mm, about 60 mm to about 130 mm, about 60 mm to about 140 mm,about 60 mm to about 150 mm, about 70 mm to about 90 mm, about 70 mm toabout 100 mm, about 70 mm to about 110 mm, about 70 mm to about 120 mm,about 70 mm to about 130 mm, about 70 mm to about 140 mm, about 70 mm toabout 150 mm, about 90 mm to about 100 mm, about 90 mm to about 110 mm,about 90 mm to about 120 mm, about 90 mm to about 130 mm, about 90 mm toabout 140 mm, about 90 mm to about 150 mm, about 100 mm to about 110 mm,about 100 mm to about 120 mm, about 100 mm to about 130 mm, about 100 mmto about 140 mm, about 100 mm to about 150 mm, about 110 mm to about 120mm, about 110 mm to about 130 mm, about 110 mm to about 140 mm, about110 mm to about 150 mm, about 120 mm to about 130 mm, about 120 mm toabout 140 mm, about 120 mm to about 150 mm, about 130 mm to about 140mm, about 130 mm to about 150 mm, or about 140 mm to about 150 mm. Insome embodiments, the display screen 4 has a display screen length 53 ofabout 40 mm, about 50 mm, about 60 mm, about 70 mm, about 90 mm, about100 mm, about 110 mm, about 120 mm, about 130 mm, about 140 mm, or about150 mm.

In some embodiments, the display screen 4 has a display screen width 55of about 57 mm. In some embodiments, the display screen 4 has a displayscreen width 55 of about 40 mm to about 150 mm. In some embodiments, thedisplay screen 4 has a display screen width 55 of at least about 40 mm.In some embodiments, the display screen 4 has a display screen width 55of at most about 150 mm. In some embodiments, the display screen 4 has adisplay screen width 55 of about 40 mm to about 50 mm, about 40 mm toabout 60 mm, about 40 mm to about 70 mm, about 40 mm to about 90 mm,about 40 mm to about 100 mm, about 40 mm to about 110 mm, about 40 mm toabout 120 mm, about 40 mm to about 130 mm, about 40 mm to about 140 mm,about 40 mm to about 150 mm, about 50 mm to about 60 mm, about 50 mm toabout 70 mm, about 50 mm to about 90 mm, about 50 mm to about 100 mm,about 50 mm to about 110 mm, about 50 mm to about 120 mm, about 50 mm toabout 130 mm, about 50 mm to about 140 mm, about 50 mm to about 150 mm,about 60 mm to about 70 mm, about 60 mm to about 90 mm, about 60 mm toabout 100 mm, about 60 mm to about 110 mm, about 60 mm to about 120 mm,about 60 mm to about 130 mm, about 60 mm to about 140 mm, about 60 mm toabout 150 mm, about 70 mm to about 90 mm, about 70 mm to about 100 mm,about 70 mm to about 110 mm, about 70 mm to about 120 mm, about 70 mm toabout 130 mm, about 70 mm to about 140 mm, about 70 mm to about 150 mm,about 90 mm to about 100 mm, about 90 mm to about 110 mm, about 90 mm toabout 120 mm, about 90 mm to about 130 mm, about 90 mm to about 140 mm,about 90 mm to about 150 mm, about 100 mm to about 110 mm, about 100 mmto about 120 mm, about 100 mm to about 130 mm, about 100 mm to about 140mm, about 100 mm to about 150 mm, about 110 mm to about 120 mm, about110 mm to about 130 mm, about 110 mm to about 140 mm, about 110 mm toabout 150 mm, about 120 mm to about 130 mm, about 120 mm to about 140mm, about 120 mm to about 150 mm, about 130 mm to about 140 mm, about130 mm to about 150 mm, or about 140 mm to about 150 mm. In someembodiments, the display screen 4 has a display screen width 55 of about40 mm, about 50 mm, about 60 mm, about 70 mm, about 90 mm, about 100 mm,about 110 mm, about 120 mm, about 130 mm, about 140 mm, or about 150 mm.

FIG. 4B shows a side view of the tactile sensing device 400. In someembodiments, the tactile sensing device 400 comprises a sensorattachment area 52. In some embodiments, sensor attachment area 52receives a sensor array (not shown in FIGS. 4A-B). In some embodiments,sensor attachment area 52 is located on the posterior surface of thetactile sensing device 400. In some embodiments, the sensor attachmentarea 52 comprises a slit corresponding in shape and size to the slotopening 38 a and needle guide 2. In some embodiments, needle guide 2 hasa proximal opening 134 a and a distal opening 134 b, with respect to theuser, as shown in FIG. 4B. In some embodiments, the frame 20 comprises abattery 48. In some embodiments, the battery 48 is located on theposterior side of the tactile sensing device 400, as shown in FIG. 4B.In some embodiments, the battery 48 is located within the frame 20, inthe handle area. In some embodiments, the battery 48 is located on theposterior surface of the display screen 4, as shown in FIG. 4B. In someembodiments, the battery 48 is located beneath the display screen 4. Insome embodiments, the tactile sensing device 400 comprises a printedcircuit board (PCB) 50 sitting on the anterior surface of the sensorattachment area 52, within the frame 20. In some embodiments, thetactile sensing device 400 comprises a printed circuit board (PCB) 50located directly sitting on the anterior surface of the sensor array,within the frame 20. In some embodiments, the PCB 50 is located over thesensor array, within the frame 20. In some embodiments, the printedcircuit board (PCB) 50 is located within the frame 20. In someembodiments, an additional printed circuit board is located between thebattery 48 and the display screen 4.

In some embodiments, the needle guide 2 is angled. In some embodiments,the needle guide 2 is at an angle with respect to the sensor array (notshown in FIGS. 4A-B). In some embodiments, the needle guide 2 is at anangle with respect to the sensor attachment area 52. In someembodiments, the needle guide 2 is at an angle with respect to theposterior or bottom surface of the tactile sensing device 400. In someembodiments, the angle is a treatment angle 86, as shown in FIG. 4B. Insome embodiments, the needle guide forms a treatment angle 86 withrespect to the sensor array. In some embodiments, the needle guide formsa treatment angle 86 with respect to the posterior surface of thetactile sensing device 400. In some embodiments, the track (not shown inFIGS. 4A-B) forms a treatment angle 86 with respect to the sensor array.In some embodiments, the track forms a treatment angle 86 with respectto the posterior surface of the tactile sensing device 400. In someembodiments, the needle is guided at a treatment angle 86 when insertedin the needle guide 2 and advanced along the track of the needle guide.In some embodiments, the treatment angle 86 is a cephalad angle. In someembodiments, the needle is pointed towards the head or the anterior endof the body of a patient when guided at a cephalad angle. In someembodiments, the treatment angle 86 is a cephalad angle when the userplaces the tactile sensing device 400 such that the anterior end of thetactile sensing device 400 is pointed towards the anterior end of thebody of the patient. In some embodiments, the treatment angle 86 is acephalad angle when the user places the needle in the needle guide andangles the needle away from the upper face 39 of the slot. In someembodiments, the treatment angle 86 is a caudal angle. In someembodiments, the needle is pointed towards the feet or the posterior endof the body of a patient when guided at a cephalad angle. In someembodiments, the treatment angle 86 is a caudal angle when the patientis in a lateral decubitus position. In some embodiments, the treatmentangle 86 is a caudal angle when the user places the tactile sensingdevice 400 such that the anterior end of the tactile sensing device 400is pointed towards the posterior end of the body of the patient.

In some embodiments, the treatment angle is about 30 degrees to about 90degrees. In some embodiments, the treatment angle is about 69 degrees toabout 81 degrees. In some embodiments, the treatment angle is at leastabout 30 degrees. In some embodiments, the treatment angle is at mostabout 90 degrees. In some embodiments, the treatment angle is about 30degrees to about 35 degrees, about 30 degrees to about 40 degrees, about30 degrees to about 45 degrees, about 30 degrees to about 50 degrees,about 30 degrees to about 55 degrees, about 30 degrees to about 60degrees, about 30 degrees to about 65 degrees, about 30 degrees to about70 degrees, about 30 degrees to about 75 degrees, about 30 degrees toabout 80 degrees, about 30 degrees to about 90 degrees, about 35 degreesto about 40 degrees, about 35 degrees to about 45 degrees, about 35degrees to about 50 degrees, about 35 degrees to about 55 degrees, about35 degrees to about 60 degrees, about 35 degrees to about 65 degrees,about 35 degrees to about 70 degrees, about 35 degrees to about 75degrees, about 35 degrees to about 80 degrees, about 35 degrees to about90 degrees, about 40 degrees to about 45 degrees, about 40 degrees toabout 50 degrees, about 40 degrees to about 55 degrees, about 40 degreesto about 60 degrees, about 40 degrees to about 65 degrees, about 40degrees to about 70 degrees, about 40 degrees to about 75 degrees, about40 degrees to about 80 degrees, about 40 degrees to about 90 degrees,about 45 degrees to about 50 degrees, about 45 degrees to about 55degrees, about 45 degrees to about 60 degrees, about 45 degrees to about65 degrees, about 45 degrees to about 70 degrees, about 45 degrees toabout 75 degrees, about 45 degrees to about 80 degrees, about 45 degreesto about 90 degrees, about 50 degrees to about 55 degrees, about 50degrees to about 60 degrees, about 50 degrees to about 65 degrees, about50 degrees to about 70 degrees, about 50 degrees to about 75 degrees,about 50 degrees to about 80 degrees, about 50 degrees to about 90degrees, about 55 degrees to about 60 degrees, about 55 degrees to about65 degrees, about 55 degrees to about 70 degrees, about 55 degrees toabout 75 degrees, about 55 degrees to about 80 degrees, about 55 degreesto about 90 degrees, about 60 degrees to about 65 degrees, about 60degrees to about 70 degrees, about 60 degrees to about 75 degrees, about60 degrees to about 80 degrees, about 60 degrees to about 90 degrees,about 65 degrees to about 70 degrees, about 65 degrees to about 75degrees, about 65 degrees to about 80 degrees, about 65 degrees to about90 degrees, about 70 degrees to about 75 degrees, about 70 degrees toabout 80 degrees, about 70 degrees to about 90 degrees, about 75 degreesto about 80 degrees, about 75 degrees to about 90 degrees, or about 80degrees to about 90 degrees.

In some embodiments, the treatment angle is about 30 degrees. In someembodiments, the treatment angle is about 35 degrees. In someembodiments, the treatment angle is about 40 degrees. In someembodiments, the treatment angle is about 45 degrees. In someembodiments, the treatment angle is about 50 degrees. In someembodiments, the treatment angle is about 55 degrees. In someembodiments, the treatment angle is about 60 degrees. In someembodiments, the treatment angle is about 65 degrees. In someembodiments, the treatment angle is about 70 degrees. In someembodiments, the treatment angle is about 75 degrees. In someembodiments, the treatment angle is about 80 degrees. In someembodiments, the treatment angle is about 90 degrees.

In some embodiments, the treatment angle is about 69 degrees. In someembodiments, the treatment angle is about 70 degrees. In someembodiments, the treatment angle is about 71 degrees. In someembodiments, the treatment angle is about 72 degrees. In someembodiments, the treatment angle is about 73 degrees. In someembodiments, the treatment angle is about 74 degrees. In someembodiments, the treatment angle is about 75 degrees. In someembodiments, the treatment angle is about 76 degrees. In someembodiments, the treatment angle is about 77 degrees. In someembodiments, the treatment angle is about 78 degrees. In someembodiments, the treatment angle is about 79 degrees. In someembodiments, the treatment angle is about 80 degrees. In someembodiments, the treatment angle is about 81 degrees.

In some embodiments, the treatment angle 86 is a cephalad angle betweenabout 0° to about 15° with respect to the individual. In someembodiments, the treatment angle 86 is a cephalad angle between about 9°to about 21°. In some embodiments, the treatment angle 86 is a cephaladangle that is at least about 0 degrees. In some embodiments, thetreatment angle 86 is a cephalad angle that is at most about 15 degrees.In some embodiments, the treatment angle 86 is a cephalad angle that isabout 0 degrees to about 1 degree, about 0 degrees to about 2 degrees,about 0 degrees to about 3 degrees, about 0 degrees to about 4 degrees,about 0 degrees to about 5 degrees, about 0 degrees to about 6 degrees,about 0 degrees to about 7 degrees, about 0 degrees to about 8 degrees,about 0 degrees to about 9 degrees, about 0 degrees to about 10 degrees,about 0 degrees to about 15 degrees, about 1 degree to about 2 degrees,about 1 degree to about 3 degrees, about 1 degree to about 4 degrees,about 1 degree to about 5 degrees, about 1 degree to about 6 degrees,about 1 degree to about 7 degrees, about 1 degree to about 8 degrees,about 1 degree to about 9 degrees, about 1 degree to about 10 degrees,about 1 degree to about 15 degrees, about 2 degrees to about 3 degrees,about 2 degrees to about 4 degrees, about 2 degrees to about 5 degrees,about 2 degrees to about 6 degrees, about 2 degrees to about 7 degrees,about 2 degrees to about 8 degrees, about 2 degrees to about 9 degrees,about 2 degrees to about 10 degrees, about 2 degrees to about 15degrees, about 3 degrees to about 4 degrees, about 3 degrees to about 5degrees, about 3 degrees to about 6 degrees, about 3 degrees to about 7degrees, about 3 degrees to about 8 degrees, about 3 degrees to about 9degrees, about 3 degrees to about 10 degrees, about 3 degrees to about15 degrees, about 4 degrees to about 5 degrees, about 4 degrees to about6 degrees, about 4 degrees to about 7 degrees, about 4 degrees to about8 degrees, about 4 degrees to about 9 degrees, about 4 degrees to about10 degrees, about 4 degrees to about 15 degrees, about 5 degrees toabout 6 degrees, about 5 degrees to about 7 degrees, about 5 degrees toabout 8 degrees, about 5 degrees to about 9 degrees, about 5 degrees toabout 10 degrees, about 5 degrees to about 15 degrees, about 6 degreesto about 7 degrees, about 6 degrees to about 8 degrees, about 6 degreesto about 9 degrees, about 6 degrees to about 10 degrees, about 6 degreesto about 15 degrees, about 7 degrees to about 8 degrees, about 7 degreesto about 9 degrees, about 7 degrees to about 10 degrees, about 7 degreesto about 15 degrees, about 8 degrees to about 9 degrees, about 8 degreesto about 10 degrees, about 8 degrees to about 15 degrees, about 9degrees to about 10 degrees, about 9 degrees to about 15 degrees, orabout 10 degrees to about 15 degrees. In some embodiments, the treatmentangle 86 is a cephalad angle that is about 0 degrees, about 1 degree,about 2 degrees, about 3 degrees, about 4 degrees, about 5 degrees,about 6 degrees, about 7 degrees, about 8 degrees, about 9 degrees,about 10 degrees, or about 15 degrees. In some embodiments, thetreatment angle 86 is a cephalad angle that is about 10 degrees to about15 degrees. In some embodiments, the treatment angle 86 is a cephaladangle that is at least about 10 degrees. In some embodiments, thetreatment angle 86 is a cephalad angle that is at most about 15 degrees.In some embodiments, the treatment angle 86 is a cephalad angle that isabout 10 degrees to about 11 degrees, about 10 degrees to about 12degrees, about 10 degrees to about 13 degrees, about 10 degrees to about14 degrees, about 10 degrees to about 15 degrees, about 11 degrees toabout 12 degrees, about 11 degrees to about 13 degrees, about 11 degreesto about 14 degrees, about 11 degrees to about 15 degrees, about 12degrees to about 13 degrees, about 12 degrees to about 14 degrees, about12 degrees to about 15 degrees, about 13 degrees to about 14 degrees,about 13 degrees to about 15 degrees, or about 14 degrees to about 15degrees.

In some embodiments, the treatment angle 86 is a cephalad angle that isabout 9 degrees. In some embodiments, the treatment angle 86 is acephalad angle that is about 10 degrees. In some embodiments, thetreatment angle 86 is a cephalad angle that is about 11 degrees. In someembodiments, the treatment angle 86 is a cephalad angle that is about 12degrees. In some embodiments, the treatment angle 86 is a cephalad anglethat is about 13 degrees. In some embodiments, the treatment angle 86 isa cephalad angle that is about 14 degrees. In some embodiments, thetreatment angle 86 is a cephalad angle that is about 15 degrees. In someembodiments, the treatment angle 86 is a cephalad angle that is about 16degrees. In some embodiments, the treatment angle 86 is a cephalad anglethat is about 17 degrees. In some embodiments, the treatment angle 86 isa cephalad angle that is about 18 degrees. In some embodiments, thetreatment angle 86 is a cephalad angle that is about 19 degrees. In someembodiments, the treatment angle 86 is a cephalad angle that is about 20degrees. In some embodiments, the treatment angle 86 is a cephalad anglethat is about 21 degrees.

In some embodiments, the sensor array (not shown in FIGS. 4A-B) is anarray of sensor elements also known as “sensels.” In some embodiments,the sensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIGS. 4A-B), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIGS. 4A-B) is an array of cells. In someembodiments, the sensor array (not shown in FIGS. 4A-B) is an array ofsensing cells. In some embodiments, the sensor array slit (not shown inFIGS. 4A-B) is positioned between two rows or more of sensels. In someembodiments, the sensor array slit (not shown in FIGS. 4A-B) ispositioned between two columns or more of sensels. In some embodiments,the sensor array slit (not shown in FIGS. 4A-B) is within the bounds ofthe sensor array, and/or within the bounds of the sensor array outeredges, and/or within the edges bounding of the sensor array. In someembodiments, the sensor array does not comprise a slit. In someembodiments, the distal opening 134 b of the needle guide 2 ispositioned between two rows of sensels. In some embodiments, the distalopening 134 b of the needle guide 2 is positioned between two columns ofsensels. In some embodiments the distal opening 134 b of the needleguide 2 is within the bounds of the sensor array, and/or within thebounds of the sensor array outer edges, and/or within the edges boundingof the sensor array. In some embodiments, the distal opening 34 b isbetween two or more sensors of the sensor array. In some embodiments,the distal opening 34 b is positioned between two rows or more ofsensels. In some embodiments, the distal opening 34 b is positionedbetween two columns or more of sensels.

FIGS. 5-12 show the tactile sensing device comprising a display screen,a needle guide, and a handle. Specifically, FIGS. 5-12 show differentvariations and types of handles and/or grips.

FIG. 5 shows the tactile sensing device 500 comprising a handle 54 thatis an extended handle. In some embodiments, the extended handle providesnumerous advantages which include, but are not limited to, maximizingthe ability to apply force, better balance and linear movement control,separate handling area from interaction point, accommodating both leftand right handed users, easy to be used when used on both a seated and alateral decubitus-positioned individual. In some embodiments, a batteryis located inside or within the handle 54. In some embodiments, theextended handle accommodates all fingers of a user to better hold thedevice. In some embodiments, the extended handle allows the user to usehis/her thumb to apply more force on the surface where the tactilesensing device 500 is being pressed upon. In some embodiments, thetactile sensing device 500 comprises a needle guide 2 that is a fixedneedle guide. In some embodiments, the tactile sensing device 500comprises a slot opening 38 a. In some embodiments, the slot opening 38a c provides the user (i.e., holding a syringe and/or needle) withaccess to the needle guide 2. In some embodiments, the slot opening 38 aprovides an opening to remove the tactile sensing device from a needleresting on the needle guide 2.

In some embodiments, the tactile sensing device 500 has a length 49 ofabout 296 mm. In some embodiments, the tactile sensing device 500 has alength 49 of about 250 mm to about 400 mm. In some embodiments, thetactile sensing device 500 has a length 49 of at least about 250 mm. Insome embodiments, the tactile sensing device 500 has a length 49 of atmost about 400 mm. In some embodiments, the tactile sensing device 500has a length 49 of about 250 mm to about 260 mm, about 250 mm to about270 mm, about 250 mm to about 280 mm, about 250 mm to about 290 mm,about 250 mm to about 300 mm, about 250 mm to about 310 mm, about 250 mmto about 320 mm, about 250 mm to about 330 mm, about 250 mm to about 340mm, about 250 mm to about 350 mm, about 250 mm to about 400 mm, about260 mm to about 270 mm, about 260 mm to about 280 mm, about 260 mm toabout 290 mm, about 260 mm to about 300 mm, about 260 mm to about 310mm, about 260 mm to about 320 mm, about 260 mm to about 330 mm, about260 mm to about 340 mm, about 260 mm to about 350 mm, about 260 mm toabout 400 mm, about 270 mm to about 280 mm, about 270 mm to about 290mm, about 270 mm to about 300 mm, about 270 mm to about 310 mm, about270 mm to about 320 mm, about 270 mm to about 330 mm, about 270 mm toabout 340 mm, about 270 mm to about 350 mm, about 270 mm to about 400mm, about 280 mm to about 290 mm, about 280 mm to about 300 mm, about280 mm to about 310 mm, about 280 mm to about 320 mm, about 280 mm toabout 330 mm, about 280 mm to about 340 mm, about 280 mm to about 350mm, about 280 mm to about 400 mm, about 290 mm to about 300 mm, about290 mm to about 310 mm, about 290 mm to about 320 mm, about 290 mm toabout 330 mm, about 290 mm to about 340 mm, about 290 mm to about 350mm, about 290 mm to about 400 mm, about 300 mm to about 310 mm, about300 mm to about 320 mm, about 300 mm to about 330 mm, about 300 mm toabout 340 mm, about 300 mm to about 350 mm, about 300 mm to about 400mm, about 310 mm to about 320 mm, about 310 mm to about 330 mm, about310 mm to about 340 mm, about 310 mm to about 350 mm, about 310 mm toabout 400 mm, about 320 mm to about 330 mm, about 320 mm to about 340mm, about 320 mm to about 350 mm, about 320 mm to about 400 mm, about330 mm to about 340 mm, about 330 mm to about 350 mm, about 330 mm toabout 400 mm, about 340 mm to about 350 mm, about 340 mm to about 400mm, or about 350 mm to about 400 mm. In some embodiments, the tactilesensing device 500 has a length 49 of about 250 mm, about 260 mm, about270 mm, about 280 mm, about 290 mm, about 300 mm, about 310 mm, about320 mm, about 330 mm, about 340 mm, about 350 mm, or about 400 mm.

In some embodiments, the tactile sensing device 500 has a width 51 ofabout 78 mm. In some embodiments, the tactile sensing device 500 has awidth 51 of about 10 mm to about 200 mm. In some embodiments, thetactile sensing device 500 has a width 51 of at least about 10 mm. Insome embodiments, the tactile sensing device 500 has a width 51 of atmost about 200 mm. In some embodiments, the tactile sensing device 500has a width 51 of about 50 mm to about 60 mm, about 50 mm to about 70mm, about 50 mm to about 80 mm, about 50 mm to about 90 mm, about 50 mmto about 100 mm, about 50 mm to about 110 mm, about 50 mm to about 10mm, about 50 mm to about 130 mm, about 50 mm to about 140 mm, about 50mm to about 150 mm, about 50 mm to about 200 mm, about 60 mm to about 70mm, about 60 mm to about 80 mm, about 60 mm to about 90 mm, about 60 mmto about 100 mm, about 60 mm to about 110 mm, about 60 mm to about 10mm, about 60 mm to about 130 mm, about 60 mm to about 140 mm, about 60mm to about 150 mm, about 60 mm to about 200 mm, about 70 mm to about 80mm, about 70 mm to about 90 mm, about 70 mm to about 100 mm, about 70 mmto about 110 mm, about 70 mm to about 10 mm, about 70 mm to about 130mm, about 70 mm to about 140 mm, about 70 mm to about 150 mm, about 70mm to about 200 mm, about 80 mm to about 90 mm, about 80 mm to about 100mm, about 80 mm to about 110 mm, about 80 mm to about 10 mm, about 80 mmto about 130 mm, about 80 mm to about 140 mm, about 80 mm to about 150mm, about 80 mm to about 200 mm, about 90 mm to about 100 mm, about 90mm to about 110 mm, about 90 mm to about 10 mm, about 90 mm to about 130mm, about 90 mm to about 140 mm, about 90 mm to about 150 mm, about 90mm to about 200 mm, about 100 mm to about 110 mm, about 100 mm to about10 mm, about 100 mm to about 130 mm, about 100 mm to about 140 mm, about100 mm to about 150 mm, about 100 mm to about 200 mm, about 110 mm toabout 10 mm, about 110 mm to about 130 mm, about 110 mm to about 140 mm,about 110 mm to about 150 mm, about 110 mm to about 200 mm, about 10 mmto about 130 mm, about 10 mm to about 140 mm, about 10 mm to about 150mm, about 10 mm to about 200 mm, about 130 mm to about 140 mm, about 130mm to about 150 mm, about 130 mm to about 200 mm, about 140 mm to about150 mm, about 140 mm to about 200 mm, or about 150 mm to about 200 mm.In some embodiments, the tactile sensing device 500 has a width 51 ofabout 50 mm, about 60 mm, about 70 mm, about 80 mm, about 90 mm, about100 mm, about 110 mm, about 10 mm, about 130 mm, about 140 mm, about 150mm, or about 200 mm.

In some embodiments, the tactile sensing device 500 has a height 57 ofabout 81 mm. In some embodiments, the tactile sensing device 500 has aheight 57 of about 10 mm to about 150 mm. In some embodiments, thetactile sensing device 500 has a height 57 of at least about 10 mm. Insome embodiments, the tactile sensing device 500 has a height 57 of atmost about 150 mm. In some embodiments, the tactile sensing device 500has a height 57 of about 50 mm to about 60 mm, about 50 mm to about 70mm, about 50 mm to about 80 mm, about 50 mm to about 90 mm, about 50 mmto about 100 mm, about 50 mm to about 110 mm, about 50 mm to about 10mm, about 50 mm to about 130 mm, about 50 mm to about 140 mm, about 50mm to about 150 mm, about 60 mm to about 70 mm, about 60 mm to about 80mm, about 60 mm to about 90 mm, about 60 mm to about 100 mm, about 60 mmto about 110 mm, about 60 mm to about 10 mm, about 60 mm to about 130mm, about 60 mm to about 140 mm, about 60 mm to about 150 mm, about 70mm to about 80 mm, about 70 mm to about 90 mm, about 70 mm to about 100mm, about 70 mm to about 110 mm, about 70 mm to about 10 mm, about 70 mmto about 130 mm, about 70 mm to about 140 mm, about 70 mm to about 150mm, about 80 mm to about 90 mm, about 80 mm to about 100 mm, about 80 mmto about 110 mm, about 80 mm to about 10 mm, about 80 mm to about 130mm, about 80 mm to about 140 mm, about 80 mm to about 150 mm, about 90mm to about 100 mm, about 90 mm to about 110 mm, about 90 mm to about 10mm, about 90 mm to about 130 mm, about 90 mm to about 140 mm, about 90mm to about 150 mm, about 100 mm to about 110 mm, about 100 mm to about10 mm, about 100 mm to about 130 mm, about 100 mm to about 140 mm, about100 mm to about 150 mm, about 110 mm to about 10 mm, about 110 mm toabout 130 mm, about 110 mm to about 140 mm, about 110 mm to about 150mm, about 10 mm to about 130 mm, about 10 mm to about 140 mm, about 10mm to about 150 mm, about 130 mm to about 140 mm, about 130 mm to about150 mm, or about 140 mm to about 150 mm. In some embodiments, thetactile sensing device 500 has a height 57 of about 50 mm, about 60 mm,about 70 mm, about 80 mm, about 90 mm, about 100 mm, about 110 mm, about10 mm, about 130 mm, about 140 mm, or about 150 mm.

In some embodiments, the sensor array (not shown in FIG. 5) is an arrayof sensor elements also known as “sensels.” In some embodiments, thesensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIG. 5), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIG. 5) is an array of cells. In someembodiments, the sensor array (not shown in FIG. 5) is an array ofsensing cells. In some embodiments, the sensor array slit (not shown inFIG. 5) is positioned between two rows or more of sensels. In someembodiments, the sensor array slit (not shown in FIG. 5) is positionedbetween two columns or more of sensels. In some embodiments, the sensorarray slit (not shown in FIG. 5) is within the bounds of the sensorarray, and/or within the bounds of the sensor array outer edges, and/orwithin the edges bounding of the sensor array. In some embodiments, thesensor array does not comprise a slit. In some embodiments, the distalopening (not shown in FIG. 5) of the needle guide 2 is positionedbetween two rows of sensels. In some embodiments, the distal opening(not shown in FIG. 5) of the needle guide 2 is positioned between twocolumns of sensels. In some embodiments the distal opening (not shown inFIG. 5) of the needle guide 2 is within the bounds of the sensor array,and/or within the bounds of the sensor array outer edges, and/or withinthe edges bounding of the sensor array. In some embodiments, the distalopening (not shown in FIG. 5) is between two or more sensors of thesensor array. In some embodiments, the distal opening (not shown in FIG.5) is positioned between two rows or more of sensels. In someembodiments, the distal opening (not shown in FIG. 5) is positionedbetween two columns or more of sensels.

FIG. 6 shows the tactile sensing device 600 comprising a curved handle56. In some embodiments, the curved handle 56 is a reduced-sized handlecompared to the handle shown in FIG. 5. In some embodiments, thereduced-sized handle provides numerous advantages which include, but arenot limited to, enhancing the ability to apply force using a thumb,better balance and linear movement control, separate handling area frompenetration area (i.e. needle guide area), accommodating both left andright handed users, better hand posture when used on both a seated and alateral decubitus-positioned individual. In some embodiments, a batteryis located inside or within a curved handle 56. In some embodiments, thereduced-sized handle accommodates all fingers of a user to better holdthe device. In some embodiments, the reduced-sized handle allows theuser to use their prominent fingers to control the tactile sensingdevice 600. In some embodiments, the reduced-sized handle allows theuser to use his/her thumb to apply more force on the surface where thetactile sensing device 600 is being pressed upon. In some embodiments,the tactile sensing device 600 comprises a tilted display.

FIG. 6 shows the architecture of different components of the tactilesensing device 600. In some embodiments, the tactile sensing device 600comprises a frame 20 that encloses a sensor unit 32 and an electronicunit 34. In some embodiments, the sensor unit 32 is disposable. In someembodiments, the sensor unit 32 is detachable or reversibly attached tothe tactile sensing device 1300. In some embodiments, the sensor unit 32is sterile. In some embodiments, the sensor unit 32 comprises the needleguide (not shown in FIG. 6). In some embodiments, the sensor unit 32that has a length of about 50 mm to about 100 mm.

In some embodiments, the sensor unit 32 comprises a sensor attachmentarea 52. In some embodiments, the sensor attachment area 52 is sterile.In some embodiments, the sensor attachment area 52 receives a sensorarray. In some embodiments, the sensor array is adhered to the sensorattachment area 52. In some embodiments, the sensor array is ascreen-printed force-sensitive resistor (FSR) array. In someembodiments, the frame 20 comprises a printed circuit board (PCB) 50located underneath the display screen 4, as shown in FIG. 6.

In some embodiments, the tactile sensing device 600 comprises a screen(not shown in FIG. 6). In some embodiments, the display screen measures99 mm by 57 mm.

In some embodiments, the sensor unit 32 comprises a pressure sensorconnector 12, a needle guide 2, an electronic unit connector 74, and asensor array area 72. In some embodiments, the needle guide 2 issterile. In some embodiments, the needle guide 2 is at a treatment angle86 with respect to the sensor array area 72. In some embodiments, thepressure sensor connector 12 is a pressure port. In some embodiments,the pressure sensor connector 12 is sterile. In some embodiments, theelectronic unit connector 74 operatively couples the sensor unit 32 withthe electronic unit 34. In some embodiments, a battery 48 is locatedinside a handle 54.

In some embodiments, the sensor unit 32 is a disposable cassette. Insome embodiments, the disposable sensor unit is designed to minimize theoverall size of the disposable part of the tactile sensing device whilekeeping the skin and needle contact areas sterile. In some embodiments,the disposable sensor unit is inserted from the bottom or from the sideof the device. In some embodiments, the disposable sensor unit remainsin place via a snapping mechanism. The disposable sensor unit is loadedinto place in a multitude of ways. Non-limiting examples of loading thedisposable sensor unit into the tactile sensing device, include,pressing the disposable sensor unit into the tactile sensing device,including snap fit features that allow the disposable sensor unit tostay in place once loaded onto the tactile sensing device, any magneticmeans to hold the disposable sensor unit in place, any mechanical meansto hold the disposable sensor unit in place. In some embodiments, atugging string is used to snap the disposable sensor unit out of thetactile sensing device. In some embodiments the disposable sensor unitcomprises snap ledges, or other reversible means of loading thedisposable sensor unit into the tactile sensing device. In someembodiments, the disposable sensor unit remains in place simply becauseit abuts a ledge of the tactile sensing device. In some embodiments, oneor more tabs are present on the external surface of the tactile sensingdevice. In some embodiments, the disposable sensor unit is reversiblyloaded onto the tactile sensing device.

In some embodiments, the tactile sensing device 600 has a length 49 ofabout 248 mm. In some embodiments, the tactile sensing device 600 has alength 49 of about 200 mm to about 350 mm. In some embodiments, thetactile sensing device 600 has a length 49 of at least about 200 mm. Insome embodiments, the tactile sensing device 600 has a length 49 of atmost about 350 mm. In some embodiments, the tactile sensing device 600has a length 49 of about 200 mm to about 210 mm, about 200 mm to about220 mm, about 200 mm to about 230 mm, about 200 mm to about 240 mm,about 200 mm to about 250 mm, about 200 mm to about 260 mm, about 200 mmto about 270 mm, about 200 mm to about 280 mm, about 200 mm to about 290mm, about 200 mm to about 300 mm, about 200 mm to about 350 mm, about210 mm to about 220 mm, about 210 mm to about 230 mm, about 210 mm toabout 240 mm, about 210 mm to about 250 mm, about 210 mm to about 260mm, about 210 mm to about 270 mm, about 210 mm to about 280 mm, about210 mm to about 290 mm, about 210 mm to about 300 mm, about 210 mm toabout 350 mm, about 220 mm to about 230 mm, about 220 mm to about 240mm, about 220 mm to about 250 mm, about 220 mm to about 260 mm, about220 mm to about 270 mm, about 220 mm to about 280 mm, about 220 mm toabout 290 mm, about 220 mm to about 300 mm, about 220 mm to about 350mm, about 230 mm to about 240 mm, about 230 mm to about 250 mm, about230 mm to about 260 mm, about 230 mm to about 270 mm, about 230 mm toabout 280 mm, about 230 mm to about 290 mm, about 230 mm to about 300mm, about 230 mm to about 350 mm, about 240 mm to about 250 mm, about240 mm to about 260 mm, about 240 mm to about 270 mm, about 240 mm toabout 280 mm, about 240 mm to about 290 mm, about 240 mm to about 300mm, about 240 mm to about 350 mm, about 250 mm to about 260 mm, about250 mm to about 270 mm, about 250 mm to about 280 mm, about 250 mm toabout 290 mm, about 250 mm to about 300 mm, about 250 mm to about 350mm, about 260 mm to about 270 mm, about 260 mm to about 280 mm, about260 mm to about 290 mm, about 260 mm to about 300 mm, about 260 mm toabout 350 mm, about 270 mm to about 280 mm, about 270 mm to about 290mm, about 270 mm to about 300 mm, about 270 mm to about 350 mm, about280 mm to about 290 mm, about 280 mm to about 300 mm, about 280 mm toabout 350 mm, about 290 mm to about 300 mm, about 290 mm to about 350mm, or about 300 mm to about 350 mm. In some embodiments, the tactilesensing device 600 has a length 49 of about 200 mm, about 210 mm, about220 mm, about 230 mm, about 240 mm, about 250 mm, about 260 mm, about270 mm, about 280 mm, about 290 mm, about 300 mm, or about 350 mm.

In some embodiments, the tactile sensing device 600 has a width of about78 mm. In some embodiments, the tactile sensing device 600 has a widthof about 40 mm to about 150 mm. In some embodiments, the tactile sensingdevice 600 has a width of at least about 40 mm. In some embodiments, thetactile sensing device 600 has a width of at most about 150 mm. In someembodiments, the tactile sensing device 600 has a width of about 40 mmto about 50 mm, about 40 mm to about 60 mm, about 40 mm to about 70 mm,about 40 mm to about 80 mm, about 40 mm to about 90 mm, about 40 mm toabout 100 mm, about 40 mm to about 110 mm, about 40 mm to about 120 mm,about 40 mm to about 130 mm, about 40 mm to about 140 mm, about 40 mm toabout 150 mm, about 50 mm to about 60 mm, about 50 mm to about 70 mm,about 50 mm to about 80 mm, about 50 mm to about 90 mm, about 50 mm toabout 100 mm, about 50 mm to about 110 mm, about 50 mm to about 120 mm,about 50 mm to about 130 mm, about 50 mm to about 140 mm, about 50 mm toabout 150 mm, about 60 mm to about 70 mm, about 60 mm to about 80 mm,about 60 mm to about 90 mm, about 60 mm to about 100 mm, about 60 mm toabout 110 mm, about 60 mm to about 120 mm, about 60 mm to about 130 mm,about 60 mm to about 140 mm, about 60 mm to about 150 mm, about 70 mm toabout 80 mm, about 70 mm to about 90 mm, about 70 mm to about 100 mm,about 70 mm to about 110 mm, about 70 mm to about 120 mm, about 70 mm toabout 130 mm, about 70 mm to about 140 mm, about 70 mm to about 150 mm,about 80 mm to about 90 mm, about 80 mm to about 100 mm, about 80 mm toabout 110 mm, about 80 mm to about 120 mm, about 80 mm to about 130 mm,about 80 mm to about 140 mm, about 80 mm to about 150 mm, about 90 mm toabout 100 mm, about 90 mm to about 110 mm, about 90 mm to about 120 mm,about 90 mm to about 130 mm, about 90 mm to about 140 mm, about 90 mm toabout 150 mm, about 100 mm to about 110 mm, about 100 mm to about 120mm, about 100 mm to about 130 mm, about 100 mm to about 140 mm, about100 mm to about 150 mm, about 110 mm to about 120 mm, about 110 mm toabout 130 mm, about 110 mm to about 140 mm, about 110 mm to about 150mm, about 120 mm to about 130 mm, about 120 mm to about 140 mm, about120 mm to about 150 mm, about 130 mm to about 140 mm, about 130 mm toabout 150 mm, or about 140 mm to about 150 mm. In some embodiments, thetactile sensing device 600 has a width of about 40 mm, about 50 mm,about 60 mm, about 70 mm, about 80 mm, about 90 mm, about 100 mm, about110 mm, about 120 mm, about 130 mm, about 140 mm, or about 150 mm.

In some embodiments, the tactile sensing device 600 has a height 57 ofabout 72 mm. In some embodiments, the tactile sensing device 600 has aheight 57 of about 10 mm to about 100 mm. In some embodiments, thetactile sensing device 600 has a height 57 of at least about 10 mm. Insome embodiments, the tactile sensing device 600 has a height 57 of atmost about 100 mm. In some embodiments, the tactile sensing device 600has a height 57 of about 10 mm to about 20 mm, about 10 mm to about 30mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 10 mmto about 60 mm, about 10 mm to about 70 mm, about 10 mm to about 80 mm,about 10 mm to about 90 mm, about 10 mm to about 100 mm, about 20 mm toabout 30 mm, about 20 mm to about 40 mm, about 20 mm to about 50 mm,about 20 mm to about 60 mm, about 20 mm to about 70 mm, about 20 mm toabout 80 mm, about 20 mm to about 90 mm, about 20 mm to about 100 mm,about 30 mm to about 40 mm, about 30 mm to about 50 mm, about 30 mm toabout 60 mm, about 30 mm to about 70 mm, about 30 mm to about 80 mm,about 30 mm to about 90 mm, about 30 mm to about 100 mm, about 40 mm toabout 50 mm, about 40 mm to about 60 mm, about 40 mm to about 70 mm,about 40 mm to about 80 mm, about 40 mm to about 90 mm, about 40 mm toabout 100 mm, about 50 mm to about 60 mm, about 50 mm to about 70 mm,about 50 mm to about 80 mm, about 50 mm to about 90 mm, about 50 mm toabout 100 mm, about 60 mm to about 70 mm, about 60 mm to about 80 mm,about 60 mm to about 90 mm, about 60 mm to about 100 mm, about 70 mm toabout 80 mm, about 70 mm to about 90 mm, about 70 mm to about 100 mm,about 80 mm to about 90 mm, about 80 mm to about 100 mm, or about 90 mmto about 100 mm. In some embodiments, the tactile sensing device 600 hasa height 57 of about 10 mm, about 20 mm, about 30 mm, about 40 mm, about50 mm, about 60 mm, about 70 mm, about 80 mm, about 90 mm, or about 100mm.

In some embodiments, the sensor array (not shown in FIG. 6) is an arrayof sensor elements also known as “sensels.” In some embodiments, thesensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIG. 6), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIG. 6) is an array of cells. In someembodiments, the sensor array (not shown in FIG. 6) is an array ofsensing cells. In some embodiments, the sensor array slit (not shown inFIG. 6) is positioned between two rows or more of sensels. In someembodiments, the sensor array slit (not shown in FIG. 6) is positionedbetween two columns or more of sensels. In some embodiments, the sensorarray slit (not shown in FIG. 6) is within the bounds of the sensorarray, and/or within the bounds of the sensor array outer edges, and/orwithin the edges bounding of the sensor array. In some embodiments, thesensor array does not comprise a slit. In some embodiments, the distalopening (not shown in FIG. 6) of the needle guide 2 is positionedbetween two rows of sensels. In some embodiments, the distal opening(not shown in FIG. 6) of the needle guide 2 is positioned between twocolumns of sensels. In some embodiments the distal opening (not shown inFIG. 6) of the needle guide 2 is within the bounds of the sensor array,and/or within the bounds of the sensor array outer edges, and/or withinthe edges bounding of the sensor array. In some embodiments, the distalopening (not shown in FIG. 6) is between two or more sensors of thesensor array. In some embodiments, the distal opening (not shown in FIG.6) is positioned between two rows or more of sensels. In someembodiments, the distal opening (not shown in FIG. 6) is positionedbetween two columns or more of sensels.

FIG. 7 shows the tactile sensing device 700 comprising an enhancedsupport pinch grip 58. In some embodiments, the reduced-sized handleprovides numerous advantages, which include, but are not limited to,enhancing the ability to apply moderate force, an increased, mediumsized device, and using prominent fingers to hold the device. In someembodiments, a battery is located inside or within the enhanced supportpinch grip 58. In some embodiments, the surface of the enhanced supportpinch grip 58 comprises texture detail. In some embodiments, the surfaceof the enhanced support pinch grip 58 is textured. In some embodiments,the enhanced support pinch grip 58 provides the user with palm support.In some embodiments, the enhanced support pinch grip 58 allows the userto use prominent fingers to hold the tactile sensing device 700. In someembodiments, the tactile sensing device 700 comprises a fixed needleguide 2. In some embodiments, the tactile sensing device 700 comprises aslot further comprising a first slot wall 142 a and a second slot wall(not shown in FIG. 7).

In some embodiments, the tactile sensing device 700 has a length 49 ofabout 223 mm. In some embodiments, the tactile sensing device 700 has alength 49 of about 150 mm to about 300 mm. In some embodiments, thetactile sensing device 700 has a length 49 of at least about 150 mm. Insome embodiments, the tactile sensing device 700 has a length 49 of atmost about 300 mm. In some embodiments, the tactile sensing device 700has a length 49 of about 150 mm to about 200 mm, about 150 mm to about210 mm, about 150 mm to about 220 mm, about 150 mm to about 230 mm,about 150 mm to about 240 mm, about 150 mm to about 250 mm, about 150 mmto about 270 mm, about 150 mm to about 280 mm, about 150 mm to about 290mm, about 150 mm to about 300 mm, about 200 mm to about 210 mm, about200 mm to about 220 mm, about 200 mm to about 230 mm, about 200 mm toabout 240 mm, about 200 mm to about 250 mm, about 200 mm to about 270mm, about 200 mm to about 280 mm, about 200 mm to about 290 mm, about200 mm to about 300 mm, about 210 mm to about 220 mm, about 210 mm toabout 230 mm, about 210 mm to about 240 mm, about 210 mm to about 250mm, about 210 mm to about 270 mm, about 210 mm to about 280 mm, about210 mm to about 290 mm, about 210 mm to about 300 mm, about 220 mm toabout 230 mm, about 220 mm to about 240 mm, about 220 mm to about 250mm, about 220 mm to about 270 mm, about 220 mm to about 280 mm, about220 mm to about 290 mm, about 220 mm to about 300 mm, about 230 mm toabout 240 mm, about 230 mm to about 250 mm, about 230 mm to about 270mm, about 230 mm to about 280 mm, about 230 mm to about 290 mm, about230 mm to about 300 mm, about 240 mm to about 250 mm, about 240 mm toabout 270 mm, about 240 mm to about 280 mm, about 240 mm to about 290mm, about 240 mm to about 300 mm, about 250 mm to about 270 mm, about250 mm to about 280 mm, about 250 mm to about 290 mm, about 250 mm toabout 300 mm, about 270 mm to about 280 mm, about 270 mm to about 290mm, about 270 mm to about 300 mm, about 280 mm to about 290 mm, about280 mm to about 300 mm, or about 290 mm to about 300 mm. In someembodiments, the tactile sensing device 700 has a length 49 of about 150mm, about 200 mm, about 210 mm, about 220 mm, about 230 mm, about 240mm, about 250 mm, about 270 mm, about 280 mm, about 290 mm, or about 300mm.

In some embodiments, the tactile sensing device 700 has a width 51 ofabout 78 mm. In some embodiments, the tactile sensing device 700 has awidth 51 of about 50 mm to about 150 mm. In some embodiments, thetactile sensing device 700 has a width 51 of at least about 50 mm. Insome embodiments, the tactile sensing device 700 has a width 51 of atmost about 150 mm. In some embodiments, the tactile sensing device 700has a width 51 of about 50 mm to about 60 mm, about 50 mm to about 70mm, about 50 mm to about 80 mm, about 50 mm to about 90 mm, about 50 mmto about 100 mm, about 50 mm to about 110 mm, about 50 mm to about 120mm, about 50 mm to about 130 mm, about 50 mm to about 140 mm, about 50mm to about 150 mm, about 60 mm to about 70 mm, about 60 mm to about 80mm, about 60 mm to about 90 mm, about 60 mm to about 100 mm, about 60 mmto about 110 mm, about 60 mm to about 120 mm, about 60 mm to about 130mm, about 60 mm to about 140 mm, about 60 mm to about 150 mm, about 70mm to about 80 mm, about 70 mm to about 90 mm, about 70 mm to about 100mm, about 70 mm to about 110 mm, about 70 mm to about 120 mm, about 70mm to about 130 mm, about 70 mm to about 140 mm, about 70 mm to about150 mm, about 80 mm to about 90 mm, about 80 mm to about 100 mm, about80 mm to about 110 mm, about 80 mm to about 120 mm, about 80 mm to about130 mm, about 80 mm to about 140 mm, about 80 mm to about 150 mm, about90 mm to about 100 mm, about 90 mm to about 110 mm, about 90 mm to about120 mm, about 90 mm to about 130 mm, about 90 mm to about 140 mm, about90 mm to about 150 mm, about 100 mm to about 110 mm, about 100 mm toabout 120 mm, about 100 mm to about 130 mm, about 100 mm to about 140mm, about 100 mm to about 150 mm, about 110 mm to about 120 mm, about110 mm to about 130 mm, about 110 mm to about 140 mm, about 110 mm toabout 150 mm, about 120 mm to about 130 mm, about 120 mm to about 140mm, about 120 mm to about 150 mm, about 130 mm to about 140 mm, about130 mm to about 150 mm, or about 140 mm to about 150 mm. In someembodiments, the tactile sensing device 700 has a width 51 of about 50mm, about 60 mm, about 70 mm, about 80 mm, about 90 mm, about 100 mm,about 110 mm, about 120 mm, about 130 mm, about 140 mm, or about 150 mm.

In some embodiments, the tactile sensing device 700 has a height 57 ofabout 70 mm. In some embodiments, the tactile sensing device 700 has aheight 57 of about 10 mm to about 100 mm. In some embodiments, thetactile sensing device 700 has a height 57 of at least about 10 mm. Insome embodiments, the tactile sensing device 700 has a height 57 of atmost about 100 mm. In some embodiments, the tactile sensing device 700has a height 57 of about 10 mm to about 20 mm, about 10 mm to about 30mm, about 10 mm to about 40 mm, about 10 mm to about 50 mm, about 10 mmto about 60 mm, about 10 mm to about 70 mm, about 10 mm to about 80 mm,about 10 mm to about 90 mm, about 10 mm to about 100 mm, about 20 mm toabout 30 mm, about 20 mm to about 40 mm, about 20 mm to about 50 mm,about 20 mm to about 60 mm, about 20 mm to about 70 mm, about 20 mm toabout 80 mm, about 20 mm to about 90 mm, about 20 mm to about 100 mm,about 30 mm to about 40 mm, about 30 mm to about 50 mm, about 30 mm toabout 60 mm, about 30 mm to about 70 mm, about 30 mm to about 80 mm,about 30 mm to about 90 mm, about 30 mm to about 100 mm, about 40 mm toabout 50 mm, about 40 mm to about 60 mm, about 40 mm to about 70 mm,about 40 mm to about 80 mm, about 40 mm to about 90 mm, about 40 mm toabout 100 mm, about 50 mm to about 60 mm, about 50 mm to about 70 mm,about 50 mm to about 80 mm, about 50 mm to about 90 mm, about 50 mm toabout 100 mm, about 60 mm to about 70 mm, about 60 mm to about 80 mm,about 60 mm to about 90 mm, about 60 mm to about 100 mm, about 70 mm toabout 80 mm, about 70 mm to about 90 mm, about 70 mm to about 100 mm,about 80 mm to about 90 mm, about 80 mm to about 100 mm, or about 90 mmto about 100 mm. In some embodiments, the tactile sensing device 700 hasa height 57 of about 10 mm, about 20 mm, about 30 mm, about 40 mm, about50 mm, about 60 mm, about 70 mm, about 80 mm, about 90 mm, or about 100mm.

In some embodiments, the sensor array (not shown in FIG. 7) is an arrayof sensor elements also known as “sensels.” In some embodiments, thesensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIG. 7), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIG. 7) is an array of cells. In someembodiments, the sensor array (not shown in FIG. 7) is an array ofsensing cells. In some embodiments, the sensor array slit (not shown inFIG. 7) is positioned between two rows or more of sensels. In someembodiments, the sensor array slit (not shown in FIG. 7) is positionedbetween two columns or more of sensels. In some embodiments, the sensorarray slit (not shown in FIG. 7) is within the bounds of the sensorarray, and/or within the bounds of the sensor array outer edges, and/orwithin the edges bounding of the sensor array. In some embodiments, thesensor array does not comprise a slit. In some embodiments, the distalopening (not shown in FIG. 7) of the needle guide 2 is positionedbetween two rows of sensels. In some embodiments, the distal opening(not shown in FIG. 7) of the needle guide 2 is positioned between twocolumns of sensels. In some embodiments the distal opening (not shown inFIG. 7) of the needle guide 2 is within the bounds of the sensor array,and/or within the bounds of the sensor array outer edges, and/or withinthe edges bounding of the sensor array. In some embodiments, the distalopening (not shown in FIG. 7) is between two or more sensors of thesensor array. In some embodiments, the distal opening (not shown in FIG.7) is positioned between two rows or more of sensels. In someembodiments, the distal opening (not shown in FIG. 7) is positionedbetween two columns or more of sensels.

FIG. 8 shows the tactile sensing device 800 comprising an exaggeratedundercut grip 60. In some embodiments, the exaggerated undercut grip 60provides numerous advantages which include, but are not limited to, theability to apply more force with the palm of the user's hand, offering asurface area that is larger than the surface area of handle 56 shown inFIGS. 6A-D, for example, which the user uses to press or apply a force,and an integrated form factor. In some embodiments, the exaggeratedundercut grip 60 comprises a three-sided undercut wall 62 for grip. Insome embodiments, the tactile sensing device 800 measures approximately213 mm in length, 79 mm in width, and 72 mm in height.

In some embodiments, the sensor array (not shown in FIG. 8) is an arrayof sensor elements also known as “sensels.” In some embodiments, thesensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIG. 8), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIG. 8) is an array of cells. In someembodiments, the sensor array (not shown in FIG. 8) is an array ofsensing cells. In some embodiments, the sensor array slit (not shown inFIG. 8) is positioned between two rows or more of sensels. In someembodiments, the sensor array slit (not shown in FIG. 8) is positionedbetween two columns or more of sensels. In some embodiments, the sensorarray slit (not shown in FIG. 8) is within the bounds of the sensorarray, and/or within the bounds of the sensor array outer edges, and/orwithin the edges bounding of the sensor array. In some embodiments, thesensor array does not comprise a slit. In some embodiments, the distalopening (not shown in FIG. 8) of the needle guide 2 is positionedbetween two rows of sensels. In some embodiments, the distal opening(not shown in FIG. 8) of the needle guide 2 is positioned between twocolumns of sensels. In some embodiments the distal opening (not shown inFIG. 8) of the needle guide 2 is within the bounds of the sensor array,and/or within the bounds of the sensor array outer edges, and/or withinthe edges bounding of the sensor array. In some embodiments, the distalopening (not shown in FIG. 8) is between two or more sensors of thesensor array. In some embodiments, the distal opening (not shown in FIG.8) is positioned between two rows or more of sensels. In someembodiments, the distal opening (not shown in FIG. 8) is positionedbetween two columns or more of sensels.

FIG. 9 shows the tactile sensing device 900 comprising a pinch grip 64.In some embodiments, the pinch grip 64 provides numerous advantageswhich include, but are not limited to, better control to make smalladjustments in positioning of the tactile sensing device 900 withfingers, compact size, ability to apply force or press directly over thesensor array, and better control when used on a lateraldecubitus-positioned individual. In some embodiments, the pinch grip 64comprises a pressing support 66 that has an increased posterior surfacearea that allows for a user to apply force directly over the sensorarray. In some embodiments, the tactile sensing device 900 measuresapproximately 213 mm in length, 78 mm in width, and 72 mm in height.

In some embodiments, the sensor array (not shown in FIG. 9) is an arrayof sensor elements also known as “sensels.” In some embodiments, thesensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIG. 9), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIG. 9) is an array of cells. In someembodiments, the sensor array (not shown in FIG. 9) is an array ofsensing cells. In some embodiments, the sensor array slit (not shown inFIG. 9) is positioned between two rows or more of sensels. In someembodiments, the sensor array slit (not shown in FIG. 9) is positionedbetween two columns or more of sensels. In some embodiments, the sensorarray slit (not shown in FIG. 9) is within the bounds of the sensorarray, and/or within the bounds of the sensor array outer edges, and/orwithin the edges bounding of the sensor array. In some embodiments, thesensor array does not comprise a slit. In some embodiments, the distalopening (not shown in FIG. 9) of the needle guide 2 is positionedbetween two rows of sensels. In some embodiments, the distal opening(not shown in FIG. 9) of the needle guide 2 is positioned between twocolumns of sensels. In some embodiments the distal opening (not shown inFIG. 9) of the needle guide 2 is within the bounds of the sensor array,and/or within the bounds of the sensor array outer edges, and/or withinthe edges bounding of the sensor array. In some embodiments, the distalopening (not shown in FIG. 9) is between two or more sensors of thesensor array. In some embodiments, the distal opening (not shown in FIG.9) is positioned between two rows or more of sensels. In someembodiments, the distal opening (not shown in FIG. 9) is positionedbetween two columns or more of sensels.

FIG. 10 show the tactile sensing device 1000 comprising an undercut bodygrip 61. In some embodiments, the undercut body grip 61 providesnumerous advantages which include, but are not limited to, bettercontrol to make small adjustments in positioning of the tactile sensingdevice 1000 with fingers, compact size of device, integrated formfactor, and ability of a user to apply force or press directly over thesensor array. In some embodiments, the undercut body grip 61 comprisesan undercut wall 62 on its lateral side that enables the user to haveimproved handling of the device. In some embodiments, the tactilesensing device 1000 measures approximately 207 mm in length, 78 mm inwidth, and 72 mm in height.

In some embodiments, the sensor array (not shown in FIG. 10) is an arrayof sensor elements also known as “sensels.” In some embodiments, thesensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIG. 10), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIGS. 10) is an array of cells. In someembodiments, the sensor array (not shown in FIG. 10) is an array ofsensing cells. In some embodiments, the sensor array slit (not shown inFIG. 10) is positioned between two rows or more of sensels. In someembodiments, the sensor array slit (not shown in FIG. 10) is positionedbetween two columns or more of sensels. In some embodiments, the sensorarray slit (not shown in FIG. 10) is within the bounds of the sensorarray, and/or within the bounds of the sensor array outer edges, and/orwithin the edges bounding of the sensor array. In some embodiments, thesensor array does not comprise a slit. In some embodiments, the distalopening (not shown in FIG. 10) of the needle guide 2 is positionedbetween two rows of sensels. In some embodiments, the distal opening(not shown in FIG. 10) of the needle guide 2 is positioned between twocolumns of sensels. In some embodiments the distal opening (not shown inFIG. 10) of the needle guide 2 is within the bounds of the sensor array,and/or within the bounds of the sensor array outer edges, and/or withinthe edges bounding of the sensor array. In some embodiments, the distalopening (not shown in FIG. 10) is between two or more sensors of thesensor array. In some embodiments, the distal opening (not shown in FIG.10) is positioned between two rows or more of sensels. In someembodiments, the distal opening (not shown in FIG. 10) is positionedbetween two columns or more of sensels.

FIG. 11 shows the tactile sensing device 1100 comprising a power griphandle 68. In some embodiments, the power grip handle 68 enhances theability of a user to apply force or press directly over the sensorarray. In some embodiments, the power grip handle 68. In someembodiments, the tactile sensing device 1100 measures approximately 286mm in length, 78 mm in width, and 95 mm in height.

In some embodiments, the tactile sensing device measures at least about150 mm to at most about 350 mm in length. In some embodiments, thetactile sensing device measures at least about 150 mm to at most about200 mm in length. In some embodiments, the tactile sensing devicemeasures at least about 200 mm to at most about 250 mm in length. Insome embodiments, the tactile sensing device measures at least about 250mm to at most about 300 mm in length. In some embodiments, the tactilesensing device measures about 150 mm in length. In some embodiments, thetactile sensing device measures about 160 mm in length. In someembodiments, the tactile sensing device measures about 170 mm in length.In some embodiments, the tactile sensing device measures about 180 mm inlength. In some embodiments, the tactile sensing device measures about190 mm in length. In some embodiments, the tactile sensing devicemeasures about 200 mm in length. In some embodiments, the tactilesensing device measures about 210 mm in length. In some embodiments, thetactile sensing device measures about 220 mm in length. In someembodiments, the tactile sensing device measures about 230 mm in length.In some embodiments, the tactile sensing device measures about 240 mm inlength. In some embodiments, the tactile sensing device measures about250 mm in length. In some embodiments, the tactile sensing devicemeasures about 260 mm in length. In some embodiments, the tactilesensing device measures about 270 mm in length. In some embodiments, thetactile sensing device measures about 280 mm in length. In someembodiments, the tactile sensing device measures about 290 mm in length.In some embodiments, the tactile sensing device measures about 300 mm inlength. In some embodiments, the tactile sensing device measures about350 mm in length. In some embodiments, the tactile sensing devicemeasures about 316 mm in length.

In some embodiments, the tactile sensing device measures at least about50 mm to at most about 150 mm in width. In some embodiments, the tactilesensing device measures at least about 50 mm to at most about 100 mm inwidth. In some embodiments, the tactile sensing device measures at leastabout 100 mm to at most about 150 mm in width. In some embodiments, thetactile sensing device measures at least about 50 mm to at most about 80mm in width. In some embodiments, the tactile sensing device measuresabout 70 mm in width. In some embodiments, the tactile sensing devicemeasures about 75 mm in width. In some embodiments, the tactile sensingdevice measures about 80 mm in width. In some embodiments, the tactilesensing device measures about 85 mm in width. In some embodiments, thetactile sensing device measures about 100 mm in width. In someembodiments, the tactile sensing device measures about 150 mm in width.In some embodiments, the tactile sensing device measures about 50 mm inwidth. In some embodiments, the tactile sensing device measures about 60mm in width. In some embodiments, the tactile sensing device measuresabout 78 mm in width. In some embodiments, the tactile sensing devicemeasures about 79 mm in width. In some embodiments, the tactile sensingdevice measures about 77 mm in width.

In some embodiments, the sensor array (not shown in FIG. 11) is an arrayof sensor elements also known as “sensels.” In some embodiments, thesensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIG. 11), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIG. 11) is an array of cells. In someembodiments, the sensor array (not shown in FIG. 11) is an array ofsensing cells. In some embodiments, the sensor array slit (not shown inFIG. 11) is positioned between two rows or more of sensels. In someembodiments, the sensor array slit (not shown in FIG. 11) is positionedbetween two columns or more of sensels. In some embodiments, the sensorarray slit (not shown in FIG. 11) is within the bounds of the sensorarray, and/or within the bounds of the sensor array outer edges, and/orwithin the edges bounding of the sensor array. In some embodiments, thesensor array does not comprise a slit. In some embodiments, the distalopening (not shown in FIG. 11) of the needle guide 2 is positionedbetween two rows of sensels. In some embodiments, the distal opening(not shown in FIG. 11) of the needle guide 2 is positioned between twocolumns of sensels. In some embodiments the distal opening (not shown inFIG. 11) of the needle guide 2 is within the bounds of the sensor array,and/or within the bounds of the sensor array outer edges, and/or withinthe edges bounding of the sensor array. In some embodiments, the distalopening (not shown in FIG. 11) is between two or more sensors of thesensor array. In some embodiments, the distal opening (not shown in FIG.11) is positioned between two rows or more of sensels. In someembodiments, the distal opening (not shown in FIG. 11) is positionedbetween two columns or more of sensels.

In some embodiments, the tactile sensing device comprises an angleddisplay screen. In some embodiments, the display screen 4 is at adisplay angle with respect to the sensor array. In some embodiments, theangled display screen is at a display angle with respect to theposterior surface of the tactile sensing device. In some embodiments,the angled display screen provides more visibility when used on a seatedindividual compared to when used on a lateral decubitus-positionedindividual. In some embodiments, the tactile sensing device comprises aflat display screen. In some embodiments, the flat display screen isparallel to the sensor array. In some embodiments, the flat displayscreen is parallel to the posterior surface of the tactile sensingdevice. In some embodiments, the flat display screen is at a displayangle of zero degrees with respect to the posterior surface of thetactile sensing device. In some embodiments, the display angle isadjustable. In some embodiments, the display is manually orautomatically adjustable. In some embodiments, the flat display screenprovides good visibility when used on a seated individual and when usedon a lateral decubitus-positioned individual.

FIGS. 12A-C show a tactile sensing device 1200 comprising a sleeve 80,an electronic unit 34, and a sensor unit 32. FIGS. 12A-C show differentdesigns of the tactile sensing device 1200, particularly differentfeatures of the handle 54. For example, in some embodiments, the tactilesensing device 1200 comprises a handle 54 comprising a texture feature82 and a needle alignment guide 36, as shown in FIG. 12A. In someembodiments, the texture feature 82 provides a textured surface toincrease traction on and enhance a thumb grip. In some embodiments, thetactile sensing device 1200 comprises a grip feature 76, as shown inFIGS. 12B-C. In some embodiments, the grip feature 76 is an indentationon the handle 54 that enhances grip.

In some embodiments, the tactile sensing device comprises a largersterile area compared to the embodiments presented in FIG. 6. In someembodiments, the sensor unit 32 is disposable. In some embodiments, thesensor unit 32 comprises a handle 54. In some embodiments, the sensorunit 32 comprises a pressure sensor connector 12, a needle guide 2, anelectronic unit connector 74, and a sensor array area 72. In someembodiments, the sensor unit 32 comprises the main body of the tactilesensing device 1400. In some embodiments, the electronic unit connector74 is positioned distally away from the pressure sensor connector 12. Insome embodiments, the electronic unit connector 74 operatively couplesthe sensor unit 32 with the electronic unit 34. In some embodiments, theelectronic unit connector 74 is a male connector. In some embodiments,the sensor unit 32 comprises a port or female connector configured toreceive the electronic unit connector 74. In some embodiments, theelectronic unit connector 74 operatively couples the sensor unit 32 withthe electronic unit 34 when the electronic unit connector 74 is insertedinto a port or female connector located in the sensor unit 32. In someembodiments, the sensor unit 32 is operatively coupled to the electronicunit 34 by sliding the sensor unit 32 into a socket in the electronicunit 34, where the electronic connectors are located.

In some embodiments, the tactile sensing device comprises a sleeve 80.In some embodiments, the sleeve 80 enables the tactile sensing device toachieve complete sterility during use. In some embodiments, having twosterile disposable units completely covers the electronic unit connectorand a sensor unit connector.

FIGS. 12 A-B are front views of two different embodiments of the tactilesensing device 1200 that illustrate how the sleeve 80 slides onto theelectronic unit 34. Additionally, in some embodiments, FIGS. 12 A-Billustrate how the electronic unit 34 inserts into the sensor unit 32(note the arrows in FIGS. 12 A-C indicate the direction of movement ofeach element during assembly). FIG. 12C illustrates yet anotherembodiment of the tactile sensing device 1200 where the electronic unit34 snaps onto the distal portion of the tactile sensing device 1200, andthe sleeve 80 snaps onto the electronic unit 34, as shown by the arrows.In some embodiments, the sleeve 80 is loaded onto the electronic unitvia a snap-on mechanism, as shown in FIG. 12C. In some embodiments, theelectronic unit 34 is loaded onto the sensor unit via a snap-onmechanism, as shown in FIG. 12C.

In some embodiments, the electronic unit 34 is reversibly loaded ontothe sensor unit from the top of the device. In some embodiments, theelectronic unit 34 reversibly and operatively connects to the sensorunit 32 and/or the tactile sensing device via a magnetic force. In someembodiments, the electronic unit 34 comprises a magnet. In someembodiments, the distal portion of the tactile sensing device comprisesa magnet. In some embodiments, the sleeve 80 reversibly attaches to theelectronic unit 34 and/or to the tactile sensing device via a magneticforce. In some embodiments, the sleeve 80 comprises a magnet. In someembodiments, the electronic unit 34 is reversibly and operativelyconnected to the tactile sensing device and/or to the sensor unit 32 byany other suitable means (e.g., by using one or more clips, one or morefasteners, and/or one or more clamps). In some embodiments, the sleeve80 is reversibly and operatively connected to the tactile sensing deviceand/or to the electronic unit 34 by any other suitable means (e.g., byusing one or more clips, one or more fasteners, and/or one or moreclamps).

In some embodiments, the electronic unit 34 comprises an electronic unitconnector 74. In some embodiments, the electronic unit connector 74 is atab. In some embodiments, the sleeve 80 is composed of clear plastic. Insome embodiments, the sleeve 80 is a disposable sleeve. In someembodiments, the sleeve 80 is a plastic sleeve. In some embodiments, thesleeve 80 is a reusable sleeve. In some embodiments, the sleeve 80 is asterile sleeve. In some embodiments the tactile sensing device 1200comprises a needle guide 2 comprising a rectangular shape. In someembodiments the tactile sensing device 1200 comprises a needle guide 2,wherein the needle guide 2 does not comprise a notch. In someembodiments the tactile sensing device 1200 comprises a needle guide 2,wherein the needle guide 2 only comprises a slot 38. In some embodimentsthe tactile sensing device 1200 comprises a needle guide 2, wherein theneedle guide 2 does not comprise a track. In some embodiments thetactile sensing device 1200 comprises a needle guide 2 comprising aflared proximal opening.

In some embodiments, the sensor array (not shown in FIGS. 12A-C) is anarray of sensor elements also known as “sensels.” In some embodiments,the sensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIGS. 12A-C), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIGS. 12A-C) is an array of cells. Insome embodiments, the sensor array (not shown in FIGS. 12A-C) is anarray of sensing cells. In some embodiments, the sensor array slit (notshown in FIGS. 12A-C) is positioned between two rows or more of sensels.In some embodiments, the sensor array slit (not shown in FIGS. 12A-C) ispositioned between two columns or more of sensels. In some embodiments,the sensor array slit (not shown in FIGS. 12A-C) is within the bounds ofthe sensor array, and/or within the bounds of the sensor array outeredges, and/or within the edges bounding of the sensor array. In someembodiments, the sensor array does not comprise a slit. In someembodiments, the distal opening (not shown in FIGS. 12A-C) of the needleguide 2 is positioned between two rows of sensels. In some embodiments,the distal opening (not shown in FIGS. 12A-C) of the needle guide 2 ispositioned between two columns of sensels. In some embodiments thedistal opening (not shown in FIGS. 12A-C) of the needle guide 2 iswithin the bounds of the sensor array, and/or within the bounds of thesensor array outer edges, and/or within the edges bounding of the sensorarray. In some embodiments, the distal opening (not shown in FIGS.12A-C) is between two or more sensors of the sensor array. In someembodiments, the distal opening (not shown in FIGS. 12A-C) is positionedbetween two rows or more of sensels. In some embodiments, the distalopening (not shown in FIGS. 12A-C) is positioned between two columns ormore of sensels.

FIG. 13 illustrates a sagittal section of the lumbar spine of anindividual with a first needle 14 a in the spinal canal 100, in thesubarachnoid space. The illustration of the sagittal section of thelumbar spine shows a third lumbar vertebra 88, a fourth lumbar vertebra90, and a fifth lumbar vertebra 92. FIG. 13 further shows a spinousprocess of the third lumbar vertebra (L3) 94, a spinous process of thefourth lumbar vertebra (L4) 96, and a spinous process of the fifthlumbar (L5) vertebra 98, which are located laterally across from thethird lumbar vertebra 88, from the fourth lumbar vertebra 90, and fromthe fifth lumbar vertebra 92, respectively. The illustration of thesagittal section of the lumbar spine further shows a spinal cord 102located in the space between the lumbar vertebrae and the spinousprocesses (i.e., the spinal canal). Additionally, FIG. 13 shows asubarachnoid space 100 located in the space between the lumbar vertebraeand the spinous processes and surrounding the spinal cord 102. FIG. 13shows an epidural space 59, which is shown as encasing the subarachnoidspace 100. FIG. 13 further shows a tissue 104 of the individual locatedlaterally across from the spinous processes. In some embodiments, thetissue 104 is soft tissue. In some embodiments, the tissue 104 issubcutaneous adipose tissue, muscle, ligaments, tendons, and/or skin. Insome embodiments, the surface of tissue 104, as shown by the X-axis onFIG. 13, is skin.

FIG. 13 shows a first tactile sensing device 1300 a and a second tactilesensing device 1300 b placed on top of the skin of an individual. Thesecond tactile sensing device in this image is not meant to indicatethat there is a system with two devices, rather, it is meant to show howthe location the needle gets inserted into the subject might differ incases of different spinous process depths. FIG. 13 shows a first Y1-axisand a second Y2-axis that are both perpendicular to the X-axis. In someembodiments, a first needle 14 a is inserted at a first treatment angle86 a, as shown in FIG. 13. In some embodiments, the first treatmentangle 86 a is defined as the space measured in degrees between theX-axis and the first needle 14 a. In some embodiments, the firsttreatment angle 86 a is defined as the space measured in degrees betweenthe posterior surface of the tactile sensing device 1900 a and the firstneedle 14 a. In some embodiments, the first treatment angle 86 a isdefined as the space measured in degrees between a posterior face of thesensor array and the first needle 14 a.

In some embodiments, a second needle 14 b is inserted at a secondtreatment angle 86 b. In some embodiments, the second treatment angle 86b is defined as the space measured in degrees between the X-axis and thesecond needle 14 b. In some embodiments, the second treatment angle 86 bis defined as the space measured in degrees between the posteriorsurface of the second tactile sensing device 1900 b and the secondneedle 14 b. In some embodiments, the second treatment angle 86 b isdefined as the space measured in degrees between a posterior face of thesensor array and the first needle 14 b.

In some embodiments, a first needle 14 a is inserted at a first cephaladangle 85 a. In some embodiments, the first cephalad angle 85 a isdefined as the space measured in degrees between the first Y1-axis andthe first needle 14 a. In some embodiments, a second needle 14 b isshown as being inserted at a second cephalad angle 85 b. In someembodiments, the second cephalad angle 85 b is defined as the spacemeasured in degrees between the second Y2-axis and the second needle 14b. In some embodiments, the treatment angle is a cephalad angle. In someembodiments, the treatment angle is a caudal angle.

In addition, FIG. 13 shows the first tactile sensing device 1300 a beingmoved in the direction of arrow 103 resulting in the tactile sensingdevice being positioned as illustrated by the second tactile seconddevice 1300 b. In some embodiments, the user moves the tactile sensingdevice in the direction of arrow 103 in order to adjust the level atwhich the needle enters the epidural space 100. In some embodiments, theuser does not need to tilt the tactile sensing device in order to adjustthe level at which the needle enters the epidural space 100.

Furthermore, FIG. 13 shows a display screen offset 101. In someembodiments, the display screen (not shown in FIG. 13) is raised at adisplay screen offset 101 from the posterior surface of the tactilesensing device 1900. In some embodiments, the display screen is raisedat a display screen offset 101 from the posterior face of the sensorarray. In some embodiments, the display screen is raised at a displayscreen offset 101 from the skin surface of the patient when pressing thetactile sensing device against the patient.

In some embodiments, the display screen offset 101 is about 17 mm. Insome embodiments, the display screen offset 101 is about 5 mm. In someembodiments, the display screen offset 101 is about 10 mm. In someembodiments, the display screen offset 101 is about 11 mm. In someembodiments, the display screen offset 101 is about 12 mm. In someembodiments, the display screen offset 101 is about 13 mm. In someembodiments, the display screen offset 101 is about 14 mm. In someembodiments, the display screen offset 101 is about 15 mm. In someembodiments, the display screen offset 101 is about 16 mm. In someembodiments, the display screen offset 101 is about 18 mm. In someembodiments, the display screen offset 101 is about 19 mm. In someembodiments, the display screen offset 101 is about 20 mm. In someembodiments, the display screen offset 19101 is about 25 mm. In someembodiments, the display screen offset 101 is about 30 mm. In someembodiments, the display screen offset 101 is about 35 mm. In someembodiments, the display screen offset 101 is about 40 mm. In someembodiments, the display screen offset 101 is about 45 mm. In someembodiments, the display screen offset 101 is about 50 mm.

In some embodiments, the display screen offset 101 is at least about 1mm to about 5 mm at most. In some embodiments, the display screen offset101 is at least about 5 mm to about 10 mm at most. In some embodiments,the display screen offset 101 is at least about 10 mm to about 15 mm atmost. In some embodiments, the display screen offset 101 is at leastabout 15 mm to about 20 mm at most. In some embodiments, the displayscreen offset 101 is at least about 20 mm to about 25 mm at most. Insome embodiments, the display screen offset 101 is at least about 25 mmto about 30 mm at most. In some embodiments, the display screen offset101 is at least about 30 mm to about 35 mm at most. In some embodiments,the display screen offset 101 is at least about 35 mm to about 40 mm atmost. In some embodiments, the display screen offset 101 is at leastabout 40 mm to about 45 mm at most. In some embodiments, the displayscreen offset 101 is at least about 45 mm to about 50 mm at most. Insome embodiments, the display screen offset 101 is at least about 50 mmto about 55 mm at most. In some embodiments, the display screen offset101 is at least about 55 mm to about 60 mm at most. In some embodiments,the display screen offset 101 is at least about 1 mm to about 100 mm ormore.

In some embodiments, the display screen is at a display screen angle 99with respect to the display screen offset 101. In some embodiments, thedisplay screen rotates relative to the sensor array around a hinge toadjust the display screen angle 99. In some embodiments, the displayscreen rotates relative to the sensor unit around a hinge to adjust thedisplay screen angle 99. In some embodiments, the display screen ispivotally mounted to the tactile sensing device via hinges (not shown inFIG. 13). In some embodiments, the display screen angle 99 is manuallyadjusted by moving the display screen around a hinge (not shown).

In some embodiments, the display screen is fixed to a rotary shaft thatis further connected to the sensor array (not shown in FIG. 13). In someembodiments, the display screen is fixed to a rotary shaft that isfurther connected to the sensor unit. In some embodiments, the displayscreen rotates freely and multidirectionally relative to the sensorarray. In some embodiments, the display screen rotates freely andmultidirectionally relative to the sensor unit. In some embodiments, thedisplay screen rotates bidirectionally relative to the sensor array. Insome embodiments, the display screen rotates bidirectionally relative tothe sensor unit. In some embodiments, the display screen rotatesclockwise or counterclockwise relative to the sensor array. In someembodiments, the display screen rotates clockwise or counterclockwiserelative to the sensor unit.

In some embodiments, the display screen angle 99 is about 90 degrees. Insome embodiments, the display screen angle 99 is about 100 degrees. Insome embodiments, the display screen angle 99 is about 110 degrees. Insome embodiments, the display screen angle 99 is about 120 degrees. Insome embodiments, the display screen angle 99 is about 130 degrees. Insome embodiments, the display screen angle 99 is about 135 degrees. Insome embodiments, the display screen angle 99 is about 140 degrees. Insome embodiments, the display screen angle 99 is about 80 degrees. Insome embodiments, the display screen angle 99 is about 70 degrees. Insome embodiments, the display screen angle 99 is about 60 degrees. Insome embodiments, the display screen angle 99 is about 50 degrees. Insome embodiments, the display screen angle 99 is about 45 degrees. Insome embodiments, the display screen angle 99 is at least about 45degrees to about 140 degrees or more. In some embodiments, the displayscreen angle 99 is at least about 45 degrees to about 90 degrees atmost. In some embodiments, the display screen angle 99 is at least about90 degrees to about 140 degrees at most.

In some embodiments, the sensor array (not shown in FIG. 13) is an arrayof sensor elements also known as “sensels.” In some embodiments, thesensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIG. 13), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIG. 13) is an array of cells. In someembodiments, the sensor array (not shown in FIG. 13) is an array ofsensing cells. In some embodiments, the sensor array slit (not shown inFIG. 13) is positioned between two rows or more of sensels. In someembodiments, the sensor array slit (not shown in FIG. 13) is positionedbetween two columns or more of sensels. In some embodiments, the sensorarray slit (not shown in FIG. 13) is within the bounds of the sensorarray, and/or within the bounds of the sensor array outer edges, and/orwithin the edges bounding of the sensor array. In some embodiments, thesensor array does not comprise a slit. In some embodiments, the distalopening (not shown in FIG. 13) of the needle guide (not shown in FIG.13) is positioned between two rows of sensels. In some embodiments, thedistal opening (not shown in FIG. 13) of the needle guide (not shown inFIG. 13) is positioned between two columns of sensels. In someembodiments the distal opening (not shown in FIG. 13) of the needleguide (not shown in FIG. 13) is within the bounds of the sensor array,and/or within the bounds of the sensor array outer edges, and/or withinthe edges bounding of the sensor array. In some embodiments, the distalopening (not shown in FIG. 13) is between two or more sensors of thesensor array. In some embodiments, the distal opening (not shown in FIG.13) is positioned between two rows or more of sensels. In someembodiments, the distal opening (not shown in FIG. 13) is positionedbetween two columns or more of sensels.

FIG. 14 shows the assembly of the various elements of the tactilesensing device 1400. In some embodiments, the tactile sensing device1400 comprises a sleeve 80 that is slipped onto the electronic unit 34.In some embodiments, the electronic unit 34 comprises a display screen4, a graphic overlay 106, and an electronic unit connector 74. In someembodiments, the electronic unit 34 is inserted into a sensor unit 32comprising a sensor unit port (not shown in FIG. 14). In someembodiments, the sensor unit 32 comprises a needle guide 2, a pressuresensor connector 12, a slot opening 38 a, a needle alignment guide 36,and a handle 54. In some embodiments, the handle 54 comprises a gripfeature 76 to enhance grip. In some embodiments, the grip feature 76 isan indentation in the underside of the handle 54.

In some embodiments, the sensor array (not shown in FIG. 14) is an arrayof sensor elements also known as “sensels.” In some embodiments, thesensels are not discrete sensors. In some embodiments, the sensorelements or sensels are configured to connect to each other. In someembodiments, the sensor elements are arranged in a grid (not shown inFIG. 14), with each sensor element (or “sensel”) located at theintersection of a row and column. In some embodiments, the rows andcolumns are pinned out, rather than individual sensors being pinned out,as is the case with an array of discrete sensors. In some embodiments,the sensor array (not shown in FIG. 14) is an array of cells. In someembodiments, the sensor array (not shown in FIG. 14) is an array ofsensing cells. In some embodiments, the sensor array slit (not shown inFIG. 14) is positioned between two rows or more of sensels. In someembodiments, the sensor array slit (not shown in FIG. 14) is positionedbetween two columns or more of sensels. In some embodiments, the sensorarray slit (not shown in FIG. 14) is within the bounds of the sensorarray, and/or within the bounds of the sensor array outer edges, and/orwithin the edges bounding of the sensor array. In some embodiments, thesensor array does not comprise a slit. In some embodiments, the distalopening (not shown in FIG. 14) of the needle guide 2 is positionedbetween two rows of sensels. In some embodiments, the distal opening(not shown in FIG. 14) of the needle 2 is positioned between two columnsof sensels. In some embodiments the distal opening (not shown in FIG.20) of the needle guide 2 is within the bounds of the sensor array,and/or within the bounds of the sensor array outer edges, and/or withinthe edges bounding of the sensor array. In some embodiments, the distalopening (not shown in FIG. 14) is between two or more sensors of thesensor array. In some embodiments, the distal opening (not shown in FIG.14) is positioned between two rows or more of sensels. In someembodiments, the distal opening (not shown in FIG. 14) is positionedbetween two columns or more of sensels.

FIG. 15 shows an exploded view of the sensor array. In some embodiments,the sensor array comprises an elastomer on the patient-facing side toimprove force output and/or tissue displacement. In some embodiments,the sensor array is a screen-printed force-sensitive resistor (FSR)array 108. In some embodiments, the screen-printed force-sensitiveresistor (FSR) array 108 comprises a lower circuit 110, a spacer 112, anFSR layer 114, and an adhesive 116. In some embodiments, thescreen-printed force-sensitive resistor (FSR) array 108 is constructedby first placing the spacer 112 directly over the lower circuit 110,then placing the FSR layer 114 directly over the spacer 112, and finallyplacing the adhesive 116 directly over the FSR layer 114. In someembodiments, the screen-printed force-sensitive resistor (FSR) array 108is adhered to the posterior surface of the tactile sensing device byusing the adhesive 116. In some embodiments, the screen-printedforce-sensitive resistor (FSR) array 108 comprises a sensor array slit146. In some embodiments, the screen-printed force-sensitive resistor(FSR) array 108 does not comprise a sensor array slit 146. In someembodiments, the sensor array slit 146 is directly aligned with slotfeatured in some of the embodiments, presented herein (e.g. slot opening38 a in FIG. 14). In some embodiments, the sensor array slit 146 matchesthe posterior surface design and shape of the tactile sensing device.

In some embodiments, the sensor array slit 146 is positioned between tworows or more of sensels. In some embodiments, the sensor array slit 146is positioned between two columns or more of sensels. In someembodiments, the sensor array slit 146 is within the bounds of thesensor array, and/or within the bounds of the sensor array outer edges,and/or within the edges bounding of the sensor array. In someembodiments, the distal opening (not shown in FIG. 15) of the needleguide (not shown in FIG. 15) is positioned between two rows of sensels.In some embodiments, the distal opening (not shown in FIG. 15) of theneedle (not shown in FIG. 15) is positioned between two columns ofsensels. In some embodiments the distal opening (not shown in FIG. 15)of the needle guide (not shown in FIG. 15) is within the bounds of thesensor array, and/or within the bounds of the sensor array outer edges,and/or within the edges bounding of the sensor array. In someembodiments, the distal opening (not shown in FIG. 15) is between two ormore sensors of the sensor array. In some embodiments, the distalopening (not shown in FIG. 15) is positioned between two rows or more ofsensels. In some embodiments, the distal opening (not shown in FIG. 15)is positioned between two columns or more of sensels.

FIG. 16 shows how the screen-printed force-sensitive resistor (FSR)array 108 is adhered onto the posterior surface of the tactile sensingdevice 2200. In some embodiments, the screen-printed force-sensitiveresistor (FSR) array 108 is adhered onto the sensor attachment area 52.As seen in FIG. 16, the sensor array slit 146 is the same shape and sizeas the slot 38 of the device, which enables the user to slide the needlethrough the slot 38 without any obstructions. In some embodiments, thescreen-printed force-sensitive resistor (FSR) array 108 comprises aconductive adhesive 118 configured to operatively couple thescreen-printed force-sensitive resistor (FSR) array 108 with a printedcircuit board (not shown in FIG. 16). In dome embodiments, thescreen-printed force-sensitive resistor (FSR) array 108 comprises aconnector configured to operatively couple the array 108 with theprinted circuit board, such as a zero insertion force electricalconnector. In some embodiments, the part of the screen-printedforce-sensitive resistor (FSR) array 108 comprising (i.e., the partresembles a tab in FIG. 16) a conductive adhesive 118 is folded into asensor array slot 147 of the tactile sensing device. In someembodiments, the sensor array slot 147 is slot located along a lateraledge of the bottom surface of the tactile sensing device, as shown inFIG. 16. In some embodiments, the sensor array slot 147 is located alongany edge of the bottom surface of the tactile sensing device. In someembodiments, the sensor array slot 147 is a slot that is configured toreceive the conductive adhesive 118. In some embodiments, the conductiveadhesive 118 is inserted into the sensor array slot 147 in order tooperatively connect the FSR array to one or more electronic componentsof the tactile sensing device. Also shown in FIG. 16, is a posteriorface 109 of the sensor array 108. In some embodiments, the posteriorface 109 comes in contact with the skin surface of a patient. In someembodiments, the posterior face 109 is located on the posterior surfaceof the tactile sensing device 2200. In some embodiments, a tail of thesensor array will terminate with a connector, which will further beassembled with an intermediary PCBA in disposable versions of the devicedescribed herein (requiring some sort of connector, e.g. a zeroinsertion force connector, or a Z-axis adhesive). In some embodiments,the intermediary PCBA will comprise a durable connector, thatfacilitates connection with the reusable portion of the device (e.g. viaa card-edge connector).

In some embodiments, the sensor array slit 146 is positioned between tworows or more of sensels. In some embodiments, the sensor array slit 146is positioned between two columns or more of sensels. In someembodiments, the sensor array slit 146 is within the bounds of thesensor array, and/or within the bounds of the sensor array outer edges,and/or within the edges bounding of the sensor array. In someembodiments, the distal opening (not shown in FIG. 16) of the needleguide (not shown in FIG. 16) is positioned between two rows of sensels.In some embodiments, the distal opening (not shown in FIG. 16) of theneedle (not shown in FIG. 16) is positioned between two columns ofsensels. In some embodiments the distal opening (not shown in FIG. 16)of the needle guide (not shown in FIG. 16) is within the bounds of thesensor array, and/or within the bounds of the sensor array outer edges,and/or within the edges bounding of the sensor array. In someembodiments, the distal opening (not shown in FIG. 16) is between two ormore sensors of the sensor array. In some embodiments, the distalopening (not shown in FIG. 16) is positioned between two rows or more ofsensels. In some embodiments, the distal opening (not shown in FIG. 16)is positioned between two columns or more of sensels.

In some embodiments, the sensor array is a tactile sensor array. In someembodiments, the sensor array is an ultrasound sensor array. In someembodiments, the sensor array is an infrared radiation (IR) sensorarray. Sensor array is a sensor array cartridge that is pressed into asensor array holder. In some embodiments, the sensor array turns on onceit is loaded into the sensor array holder.

The sensors in the sensor array generate output voltage signals when theuser applies a force using the tactile sensing device onto a surface,for example, onto a tissue of a patient. The sensor array is operativelyconnected to the display screen and a computing device (not shown in inthe figures). The sensor array relays its output voltage signals to thecomputing device (not shown in FIGS. 1A and 1B), the computing deviceprocesses the output voltage signals, and an image of the output voltagesignals is visualized on the display screen.

In some embodiments, a method of using a tactile sensing device toobtain an image comprises a first step comprising pressing the tactilesensing device against an area that is to be imaged and pressing orapplying force to the sensor array of the tactile sensing device. Insome embodiments, in second a step, a computing device is provided, andthe computing device is operatively connected to the tactile sensingdevice. In some embodiments, the computing device is operativelyconnected to the display screen, the sensor array, and optionallyconnected to a pressure sensor. In some embodiments, the computingdevice collects voltage signals that are generated by the sensor arrayof the tactile sensing device after a force is applied onto the surfaceof the sensors in the sensor array. In a third step, the computingdevice processes the collected voltage signals such that the voltagesignals are converted into an image. In fourth step, the image isdisplayed on a display screen of the tactile sensing device. In someembodiments, the image displayed is a heat map. In some embodiments, theimage displayed provides the user feedback regarding the uniformity oftheir application of force to the tactile sensing device. In someembodiments, the image displayed includes the approximate position of aneedle at the skin surface as well as the approximate depth of a needle.In some embodiments, the pressure map is a three-dimensional display ofa target tissue location (e.g. vertebral features). In some embodiments,the three-dimensional display entails acquiring, registering, andvisualizing pressure data at varying depths. In some embodiments, thethree-dimensional display is achieved with an actuated system. In someembodiments, the depth detection algorithm facilitates a collection ofdepth (i.e. z-axis) layers, resulting in a three-dimensional display.

Computer Control Systems

The present disclosure provides computer control systems that areprogrammed to implement methods of the disclosure. FIG. 17 shows acomputer system 201 that is programmed or otherwise configured to outputa signal in response to a change in pressure applied to its surface;wherein the signal is converted to a pressure map. In some embodiments,the computer system 201 regulates various aspects of the tactile sensingdevice of the present disclosure, such as, for example, calculate aprojected subcutaneous needle location, display the projectedsubcutaneous location of a needle in real time, display the originalinsertion site of the needle (i.e., original needle location) in realtime, and output a pressure map corresponding to the output signalstransmitted by the sensor array also in real time. In some embodiments,the computer system 201 is an electronic device of a user or a computersystem that is remotely located with respect to the electronic device.In some embodiments, the electronic device is a mobile electronicdevice. In some embodiments, the electronic device is located within thetactile sensing device.

The computer system 201 includes a central processing unit (CPU, also“processor” and “computer processor” herein) 205. In some embodiments,the CPU20 205 is a single core or multi core processor. In someembodiments, the computer system 201 includes a plurality of processorsfor parallel processing. The computer system 201 also includes memory ormemory location 210 (e.g., random-access memory, read-only memory, flashmemory), electronic storage unit 215 (e.g., hard disk), communicationinterface 220 (e.g., network adapter) for communicating with one or moreother systems, and peripheral devices 225, such as cache, other memory,data storage and/or electronic display adapters. In some embodiments,the memory 210, storage unit 215, interface 220 and peripheral devices225 are in communication with the CPU 205 through a communication bus(solid lines), such as a motherboard. In some embodiments, the storageunit 215 is a data storage unit (or data repository) for storing data.In some embodiments, the computer system 201 is operatively coupled to acomputer network (“network”) 230 with the aid of the communicationinterface 220. In some embodiments, the network 230 is the Internet, aninternet and/or extranet, or an intranet and/or extranet that is incommunication with the Internet. In some embodiments, the network 230 insome cases is a telecommunication and/or data network. In someembodiments, the network 230 includes one or more computer servers,which enable distributed computing, such as cloud computing. In someembodiments, the network 230, in some cases with the aid of the computersystem 201, implements a peer-to-peer network, which enables devicescoupled to the computer system 201 to behave as a client or a server.

In some embodiments, the CPU 205 executes a sequence of machine-readableinstructions, which are embodied in a program or software. In someembodiments, the instructions may be stored in a memory location, suchas the memory 210. In some embodiments, the instructions are directed tothe CPU 205, which subsequently program or otherwise configure the CPU205 to implement methods of the present disclosure. Examples ofoperations performed by the CPU 205 include fetch, decode, execute, andwriteback.

In some embodiments, the CPU 205 is part of a circuit, such as anintegrated circuit. In some embodiments, one or more other components ofthe system 201 are included in the circuit. In some cases, the circuitis an application specific integrated circuit (ASIC).

In some embodiments, the storage unit 215 stores files, such as drivers,libraries and saved programs. In some embodiments, the storage unit 205stores user data, e.g., user preferences and user programs. In someembodiments, the computer system 201 in some cases includes one or moreadditional data storage units that are external to the computer system201, such as located on a remote server that is in communication withthe computer system 201 through an intranet or the Internet.

In some embodiments, the computer system 201 communicates with one ormore remote computer systems through the network 230. For instance, thecomputer system 201 communicates with a remote computer system of auser. Examples of remote computer systems include personal computers(e.g., portable PC), slate or tablet PC's (e.g., Apple® iPad, Samsung®Galaxy Tab), telephones, Smart phones (e.g., Apple® iPhone,Android-enabled device, Blackberry®), or personal digital assistants. Insome embodiments, the user accesses the computer system 201 via thenetwork 230.

Methods as described herein are implemented by way of machine (e.g.,computer processor) executable code stored on an electronic storagelocation of the computer system 1, such as, for example, on the memory210 or electronic storage unit 215. In some embodiments, the machineexecutable or machine-readable code is provided in the form of software.In some embodiments, during use, the code is executed by the processor5. In some cases, the code is retrieved from the storage unit 215 andstored on the memory 210 for ready access by the processor 5. In somesituations, the electronic storage unit 215 is precluded, andmachine-executable instructions are stored on memory 210.

In some embodiments, the code is pre-compiled and configured for usewith a machine having a processor adapted to execute the code, or iscompiled during runtime. In some embodiments, the code is supplied in aprogramming language that is selected to enable the code to execute in apre-compiled or as-compiled fashion.

Aspects of the systems and methods provided herein, such as the computersystem 1, are embodied in programming. In some embodiments, variousaspects of the technology are thought of as “products” or “articles ofmanufacture” typically in the form of machine (or processor) executablecode and/or associated data that is carried on or embodied in a type ofmachine-readable medium. In some embodiments, the machine-executablecode is stored on an electronic storage unit, such as memory (e.g.,read-only memory, random-access memory, flash memory) or a hard disk. Insome embodiments, “storage” type media includes any or all of thetangible memory of the computers, processors or the like, or associatedmodules thereof, such as various semiconductor memories, tape drives,disk drives and the like, which provide non-transitory storage at anytime for the software programming. In some embodiments, the entirety ofthe software or portions of the software, at times, is communicatedthrough the Internet or various other telecommunication networks. Suchcommunications, for example, enable loading of the software from onecomputer or processor into the other, for example, from a managementserver or host computer into the computer platform of an applicationserver. Thus, another type of media that bears the software elementsincludes optical, electrical and electromagnetic waves, such as usedacross physical interfaces between local devices, through wired andoptical landline networks and over various air-links. In someembodiments, the physical elements that carry such waves, such as wiredor wireless links, optical links or the like, also are considered asmedia bearing the software. As used herein, unless restricted tonon-transitory, tangible “storage” media, terms such as computer ormachine “readable medium” refer to any medium that participates inproviding instructions to a processor for execution.

Hence, in some embodiments, a machine-readable medium, such ascomputer-executable code, takes many forms, including but not limitedto, a tangible storage medium, a carrier wave medium or physicaltransmission medium. Non-volatile storage media include, for example,optical or magnetic disks, such as any of the storage devices in anycomputer(s) or the like, such as are used to implement the databases,etc. shown in the drawings. In some embodiments, volatile storage mediainclude dynamic memory, such as main memory of such a computer platform.In some embodiments, tangible transmission media include coaxial cables;copper wire and fiber optics, including the wires that comprise a buswithin a computer system. In some embodiments, carrier-wave transmissionmedia takes the form of electric or electromagnetic signals, or acousticor light waves such as those generated during radio frequency (RF) andinfrared (IR) data communications. In some embodiments, common forms ofcomputer-readable media therefore include for example: a floppy disk, aflexible disk, hard disk, magnetic tape, any other magnetic medium, aCD-ROM, DVD or DVD-ROM, any other optical medium, punch cards papertape, any other physical storage medium with patterns of holes, a RAM, aROM, a PROM and EPROM, a FLASH-EPROM, any other memory chip orcartridge, a carrier wave transporting data or instructions, cables orlinks transporting such a carrier wave, or any other medium from which acomputer may read programming code and/or data. In some embodiments,many of these forms of computer readable media are involved in carryingone or more sequences of one or more instructions to a processor forexecution.

The computer system 1 includes or is in communication with an electronicdisplay 235 that comprises a user interface (UI) 1 (alternatively calleda user interface (UI) module elsewhere herein) for providing, forexample, a real time pressure map, a real time fluid pressure reading, areal time location of a needle once it is inserted into an individual,and a projected subcutaneous location of a needle prior to insertion.Examples of UI's include, without limitation, a graphical user interface(GUI) and web-based user interface.

Methods and systems of the present disclosure are implemented by way ofone or more algorithms. In some embodiments, an algorithm is implementedby way of software upon execution by the central processing unit 205. Insome embodiments, the algorithm, for example, calculates a real timeprojected subcutaneous needle location prior to insertion, acquires aplurality of voltage signals, and converts them into a pressure sensorarray.

In some embodiments, a sensor array comprising at least one sensor isconfigured to output a signal in response to a change in pressureapplied to its surface; wherein the signal is converted to a pressuremap. In a first step, the output voltage signals generated by theforce-sensitive resistors via a voltage divider are inputted into thecomputing device via a multiplexer. In a second step, the inputtedvoltage signals are written to a serial monitor. In some embodiments,the second step further comprises organizing the inputted voltagesignals. In some embodiments, a first computer program that includesinstructions executable by a processor performs the second step. In someembodiments, the instructions to perform the second step, which areincluded in the computer program, are written in Arduino programminglanguage. In third step, a second computer program includes instructionsto acquire the inputted voltage signals that were written to the serialmonitor and generates an array of sensor data. In some embodiments, theinstructions to perform the third step, which are included in the secondcomputer program, are executable by a processor. In a fourth step, asecond computer program includes instructions to process the inputtedvoltage signals that were written to the serial monitor and rescales thepreviously generated array of sensor data to a second array of sensordata. In some embodiments, the instructions to perform the fourth stepuse cubic interpolation methods to rescale the array of sensor data. Insome embodiments, the instructions to perform the fourth step, which areincluded in the second computer program, are executable by a processor.In a fifth step, a second computer program includes instructions toupdate the display for real-time target tissue visualization. In someembodiments, the instructions to perform the third, fourth, and fifthsteps, which are included in the second computer program are written inPython programming language. In some embodiments, the display is updatedfor real-time visualization of a patient's spine. In some embodiments,these five steps comprise the process of transforming a sensor outputinto a visual display. In some embodiments, the visual display is apressure map.

Computing Device

In some embodiments, the tactile sensing device further comprises acomputing device. In some embodiments, the computing device is amicrocontroller. In some embodiments, the microcontroller is an 8-bit,16-bit, or 32-bit microcontroller. In some embodiments, themicrocontroller is an 8051 microcontroller, a programmable interfacecontroller (PIC), an AVR or Advanced Virtual RISC microcontroller, or anARM® microcontroller. In some embodiments, the microcontroller is, byway of non-limiting examples, an Arduino Uno microcontroller or aRaspberry Pi microcontroller.

In some embodiments, the computing device is a microprocessor. In someembodiments, the microprocessor is manufactured by AMD®, Intel®, orARM®. In some embodiments, the AMD® microprocessors include, but are notlimited to: AMD Sempron™, AMD Turion II™ AMD Athlon II™, AMD Sempron™,AMD Phenom II™, AMD A-Series, or AMD FX™. In some embodiments, theIntel® microprocessors include, but are not limited to: Intel Atom™,Intel Celeron™, Intel Pentium™, Intel Core i3™, Intel Core i5™, or IntelCore i7™. In some embodiments, the ARM® microprocessors include, but arenot limited to: ARM OMAP 3, ARM MAP 4, ARM OMAP 5, ARM SnapDragon S2,ARM SnapDragon S, ARM SnapDragon S4, ARM Tegra, ARM Tegra 2, ARM Tegra3, ARM Exynos 3 Single, ARM Exynos 4 Dual, ARM Exynos 4 Quad, ARM Exynos5 Dual, ARM A4, ARM A5, or ARM A5X.

In some embodiments, the computing device further comprises a memorydevice. In some embodiments, the processing device includes a memorydevice. A memory device is one or more physical apparatus used to storedata or programs on a temporary basis, a permanent basis, orcombinations thereof. In some embodiments, a memory device is volatileand requires power to maintain stored information. In some embodiments,a memory device is non-volatile and retains stored information and doesnot require power to maintain stored information.

In some embodiments, the computing device further comprises anon-transitory computer readable storage medium with a computer programincluding instructions executable by the processor causing the processorto convert the voltage signals into an image. In some embodiments, thecomputer program includes instructions executable by the processor thatcause the processor to encode the voltage signals into a first andsecond computer signals.

In some embodiments, the computer program includes instructionsexecutable by the processor that cause the processor to calculate aprojected needle position (i.e. location) and display it on the displayscreen. In some embodiments, the computer program includes instructionsexecutable by the processor that cause the processor to calculate aprojected needle position (i.e. location) for any potential needle guidewhen using a tactile sensing device 200 comprising a needle guidecartridge 12, as shown in FIGS. 2A and 2B. In some embodiments, a needleprojection calculation is a trigonometric algorithm. In someembodiments, the trigonometric algorithm determines the depth of theneedle once it traverses subcutaneous adipose tissue. In someembodiments, the needle projection calculation is adjusted based onamount of subcutaneous adipose tissue.

In some embodiments, the computer program includes instructionsexecutable by the processor causing the processor to: determine, as afirst requirement, a location of a bone detected by the tactile sensingdevice; ii) determine, as a second requirement, the space between saidbone structures; and iii) perform predictive analysis based onapplication of machine-learning. In some embodiments, the predictiveanalysis performed by the processor enhances the accuracy of a needleprojection calculation. In some embodiments, the predictive analysisperformed by the processor locates a desired bone and non-bonestructure. In some embodiments, the predictive analysis performed by theprocessor locates a gap between bone and non-bone structures. In someembodiments, the predictive analysis performed by the processor suggestsa needle insertion location to the user based on the voltage signalsdetected by the tactile sensing device. In some embodiments, thepredictive analysis performed by the processor comprises midlinealignment (e.g. determining rotation of detected peaks about thedevice's midline, thereby alerting user to align the device).

The computer program is, for example, software, including computeralgorithms, computer codes, programs, and data, which manages thedevice's hardware and provides services for execution of instructions.Suitable computer program languages include, by way of non-limitingexamples, C, C++, C#, Objective C, Perl, Scala, Haskell, Go, Arduino C,Python, Java, SQL, JavaScript, PHP, iOS Swift, or Ruby.

In some embodiments, the computing device is a desktop computer or alaptop computer. In some embodiments, the computing device is a mobiledevice. In some embodiments, the mobile device is a smart phone or asmart watch. In some embodiments, the computing device is a portabledevice. In accordance with the description herein, suitable computingdevices further include, by way of non-limiting examples, notebookcomputers, tablet computers, netbook computers, smart book computers,subnotebook computers, ultra-mobile PCs, handheld computers, personaldigital assistants, Internet appliances, smart phones, music players,and portable video game systems. Many mobile smart phones are suitablefor use in the systems described herein. Suitable tablet computersinclude those with booklet, slate, and convertible configurations.Suitable portable video game systems include, by way of non-limitingexamples, Nintendo DS™ and Sony PSP™

Signal Transmitter and Receiver

In some embodiments, the processor encodes the voltage signals into afirst and second computer signals. In some embodiments, the tactilesensing device comprises a signal transmitter. In some embodiments, thetactile sensing device comprises a signal receiver. In some embodiments,a transmitter is configured to transmit the first computer signal to acomputing device. In some embodiments, a receiver is configured toreceive the second computer signal from a tactile sensing device. Insome embodiments, the first and second computer signals are transmittedvia a USB (Universal Serial Bus) cable. In some embodiments, the firstand second computer signals are wireless signals.

In some embodiments, the signal receiver is a wireless element. In someembodiments, the signal transmitter is a wireless element. In someembodiments, the wireless element is configured to receive a signal froma computing device, for example, a mobile device. In some embodiments,the signal receiver is a wireless element which is configured to receivea signal from the tactile sensing device. In some embodiments, thewireless element is a wireless network technology. In some embodiments,the wireless network technology is ANT, ANT+, INSTEON, IrDA, WirelessUSB, Bluetooth, Z-Wave, or ZigBee, IEEE 802.15.4, 6LoWPAN, or Wi-Fi.

Marking Tools

In some embodiments, the tactile sensing device further comprises amarking tool. The marking tool helps the user identify the tissue targetlocation. In some embodiments, the marking tool enables the user to markthe entry point of a needle on the skin surface of the patient. In someembodiments, the marking tool enables the user to mark or label a tissuetarget location. In some embodiments, marking or labeling the tissuetarget location is done subcutaneously, intramuscularly, or on the skinsurface. In some embodiments, the marked tissue location is detected bya medical imaging device. In some embodiments, the marking tool enablesthe user to mark or label a target tissue location in order to beidentified by a medical imaging device or system. In some embodiments,the target tissue location is marked by indenting the skin over thetarget tissue location. In some embodiments, the skin over the targettissue location is indented using the posterior surface of the tactilesensing device. In some embodiments, the skin over the target tissuelocation is indented using a mechanism attached to the tactile sensingdevice. In some embodiments, the mechanism attached to the tactilesensing device is an indenting tool. In some embodiments, the skin overthe target tissue location is indented by placing an indenting toolthrough the needle guide. In some embodiments, the marking tool is alight, an ink, a hydrogel, a nanoparticle. In some embodiments, thelight is a laser light or a light emitting diode (LED). In someembodiments, the ink is a permanent ink, a gentian violent ink, awater-based ink, an oil-based in, a liquid ink, or a gel ink. In someembodiments, the hydrogel further comprises a contrast agent. In someembodiments, the nanoparticle further comprises a contrast agent. Insome embodiments, the contrast agent includes, but is not limited to: amagnetic contrast agent, a radiocontrast agent, a radioactive contrastagent, a magnetic resonance imaging contrast agent, and a microbubblecontrast agent. Non-limiting examples of the magnetic contrast agentinclude: gadolinium-based agents or nanoparticles, iron oxide-basedagents or nanoparticles, iron platinum-based agents or nanoparticles,and manganese-based agents or nanoparticles. Non-limiting examples ofthe radiocontrast agent include: iodine-based agents or nanoparticles,air, thorium dioxide, carbon dioxide, gastrografin, and barium-basedagents or nanoparticles. Non-limiting examples of the radioactivecontrast agent include: ⁶⁴Cu diacetyl-bis(N⁴-methylthiosemicarbazone),also called ATSM or Copper 64, ¹⁸F-fluorodeoxyglucose (FDG),¹⁸F-fluoride, 3′-deoxy-3′fluorothymidine (FLT), ¹⁸F-fluoromisonidazole,gallium, techtenium-99m, and thallium.

Rocker Tactile Sensing Device

In some embodiments, the tactile sensing device is a rocker tactilesensing device 1800, as shown in embodiments shown in FIGS. 18A-C,19A-C, and 20A-E, alternatively referred to herein as embodiment tactilesensing devices having rocker designs. In such embodiments, the tactilesensing devices include aspects and functionality described elsewhereherein, with the substitution of a curved sensor applicator in place ofa flat-faced sensor array, and including historical and real timevisualization as described herein. In some embodiments, the rockertactile sensing device comprises a main housing frame 19. In someembodiments, the main housing frame 19 comprises a needle alignmentguide 36. In some embodiments, the needle alignment guide 36 is anindicator for the midline of the device to facilitate alignment with thespine. In some embodiments, the needle alignment guide 36 is a coloredline. In some embodiments, the needle alignment guide 36 is a colorednotch. In some embodiments, the main housing frame 19 is reusable. Insome embodiments, the main housing frame 19 is disposable. In someembodiments, the main housing frame 19 is made of medical-grade,injection-molded plastic. In some embodiments, the main housing frame 19is comprised of two parts.

In some embodiments, the rocker tactile sensing device comprises acurved sensor applicator 13, as shown in FIG. 18B. In some embodiments,the curved sensor applicator 13 has a curvature with a radius of about1.5 inches to about 3.5 inches. In some embodiments, the curved sensorapplicator 13 is part of the main housing frame 19. In some embodiments,the curved sensor applicator 13 is assembled with the main housing frame19. In some embodiments, the curved sensor applicator 13 protrudes fromthe main housing frame 19 to allow for more concentrated application offorce. In some embodiments, the curved sensor applicator 13 is rockedrelative to a fixed main housing frame 19. In some embodiments, thecurved sensor applicator 13 is pressed against the skin surface of thepatient. In some embodiments, the sensor array captures a series ofimages when the user “rocks” the curved sensor applicator 13 against theskin surface of a patient (e.g., against the lower back of a patient, ifthe target tissue location is the lumbar vertebrae). In someembodiments, partial images of captured areas are displayed as therocking cycle is completed. In some embodiments, portions of the imagecurrently being acquired are highlighted for clarity.

In some embodiments, the tactile sensing device comprises a needle guide2 to facilitate insertion of a needle or marking tool or removal of thetactile sensing device. In some embodiments, the needle guidefacilitates insertion of a needle that is attached to a syringe. In someembodiments, the syringe is a fluid-filled syringe or an air-filledsyringe. In some embodiments, the needle guide is transparent to allowfor maximal visibility of the target tissue. In some embodiments, theneedle guide 2 is part of the curved sensor applicator. In someembodiments, the curved sensor applicator 13 comprises a needle guideinsert 25, as shown in FIG. 19A. In some embodiments, the needle guideinsert 25 comprises a needle guide 2, as shown in FIGS. 19B-C. In someembodiments, the needle guide 2 comprises a first needle guide wall 131a and a second needle guide wall 131 b. In some embodiments, the firstneedle guide wall 131 a and a second needle guide wall 131 b are incontact with a needle that is inserted into the needle guide 2. In someembodiments, the first needle guide wall 130 a and a second needle guidewall 131 b guide the angle of a needle that is inserted into the needleguide 2. In some embodiments, the first needle guide wall 131 a and asecond needle guide wall 131 b restrict the angle of a needle that isinserted into the needle guide 2. In some embodiments, the needle guideis reversibly attached to the tactile sensing device. In someembodiments, the needle comprises a notch.

In some embodiments, the needle guide insert 25 comprises a slot 38. Insome embodiments, the slot 38 comprises a first slot wall 130 a (notshown in FIGS. 19B-C) and a second slot wall 130 b (shown in FIG. 19C).In some embodiments, the slot 38 provides the user with lateral accessto the needle guide 2, as described elsewhere herein in otherembodiments. In some embodiments, the first needle guide wall 131 a anda second needle guide wall 131 b connect and form the track 144 of theneedle guide 2.

In some embodiments, the main housing frame 19 comprises a needle guiderecess 31 configured to receive the needle guide insert 25. In someembodiments, the needle guide insert 25 is removable and is assembledwith the curved sensor applicator 13. In some embodiments, the needleguide insert 25 is inserted into a needle guide recess 31. In someembodiments, the portion of the curved sensor surrounding the needleguide slot is flat to facilitate stabilization of the device duringneedle insertion. In some embodiments, the flat surface is about 0.1inches to about 1 inch in length. In some embodiments, the needle guidecomprises a needle guide opening 134 a and a needle guide terminus 134b. In some embodiments, the slot extends from the center of the sensorapplicator to the left edge of the sensor applicator, when viewed fromthe back of the device. In some embodiments, the needle guide 2comprises a wall to restrict lateral needle movement. In someembodiments, the needle guide 2 comprises a needle retention gate 17,which is engaged to prevent the needle from sliding out of the slot anddisengaged to allow the device to be removed from the needle afterinsertion. In some embodiments, the needle guide 2 is a fixed angleneedle guide. In some embodiments, the needle guide allows for about 3°of flexibility. In some embodiments, the needle guide 2 is oriented atabout 15° cephalad.

In some embodiments, the needle guide contains a mechanism that securesthe needle. In some embodiments, the securing mechanism restricts theneedle to the midline plane. In some embodiments, the securing mechanismis part of the needle guide. In some embodiments, the securing mechanismis attached to the needle guide. In some embodiments, the proximal endof the securing mechanism is filleted to allow for greater travel of theneedle hub. In some embodiments, the securing mechanism is telescopic,to allow for greater travel of the needle hub. In some embodiments, thewidth of the securing mechanism is adjusted to accommodate a variety ofneedle gauges. In some embodiments, the securing mechanism comprises oneor more parallel sets of tabs, which are separated or brought togethervia a scissor mechanism to accommodate a variety of gauges. In someembodiments, the tabs are elastic, such that smaller needles are easilyaccommodated. In some embodiments, a separation of the tabs is trackedwith an electronic sensor. In some embodiments, a separation of the tabsis determined based on markers. In some embodiments, the tabs areorientated such the distance between their outer edges is greater thanthe distance between their inner edges, which allows for support of theneedle, and facilitates easier removal of the device from the needle. Insome embodiments, separate securing mechanisms are available fordifferent needle gauges. In some embodiments, the needle is advancedthrough the securing mechanism and into the target tissue. In someembodiments, the securing mechanism is fixed relative to the needleguide. In some embodiments, the needle guide and/or the securingmechanism are rotated relative to the device. In some embodiments, thesecuring mechanism is rotated relative to the needle guide. In someembodiments, the securing mechanism is rotated to allow for insertion atany angle between about 0° and 30° cephalad. In some embodiments, theneedle guide contains markers to indicate insertion angle. In someembodiments, the securing mechanism is locked at increments betweenabout 0° and 30° cephalad to allow for fixed movement. In someembodiments, the securing mechanism is locked at about 1° increments. Insome embodiments, increments for rotation of the securing mechanism areadjusted. In some embodiments, the axis of rotation of the securingmechanism is located at the midpoint of the securing mechanism. In someembodiments, the axis of rotation of the securing mechanism is locatedat the distal end of the securing mechanism. In some embodiments, theneedle guide comprises a tab that is used to rotate the securingmechanism. In some embodiments, the needle guide comprises a dial thatis rotated to rotate the securing mechanism. In some embodiments, thesecuring mechanism is automatically rotated based on input to thedevice. In some embodiments, the needle guide comprises a mechanism thatallows the securing mechanism to release the needle after insertion. Insome embodiments, minimal retaining force allows the device to be pulledaway from the needle without the need for a release mechanism. In someembodiments, the needle guide contains a separate channel for insertionof a needle or other tool that is inserted offset from the target tissuelocation. In some embodiments, the needle guide contains a channellaterally offset from the securing mechanism that allows for insertionof a needle for local-anesthetic injection. In some embodiments, thesensor applicator is assembled with a main housing frame 19, whichcontains a slot extending from the slot in the sensor applicator to theleft edge of the main housing frame 19 when viewed from the back of thedevice.

In some embodiments, the curved sensor applicator 13 comprises a sensorarray. In some embodiments the sensor array is mounted on the curvedbottom surface of the sensor applicator via an adhesive layer spanningits active area. In some embodiments, the non-active area of the sensorfurther comprises through holes for registration with the sensorapplicator or the main housing frame 19 during assembly. In someembodiments, the sensor terminates in a zero-insertion force (ZIF)connector to connect with device sensor circuitry.

In some embodiments, the sensor array features a slot to facilitateinsertion of a needle or marking tool, and device removal. In someembodiments, the slot extends from the center of the array to the outerleft edge of the array, when observed print-side up. In someembodiments, the slot in the sensor array aligns with the needle guideslot in the sensor applicator. In some embodiments, the inner edge ofthe slot terminates in a through hole of about 2.1 millimeters (mm) indiameter at the center of the array to accommodate a needle or othermarking tool.

In some embodiments, the sensor array (not shown in FIGS. 18-26) is acalibrated, custom screen-printed sensor array that detects pressure. Insome embodiments, the sensor array comprises two thin, polyester sheets,with conductive silver traces deposited in row and column patterns onthe inner surface of each sheet, respectively. In some embodiments, thepolyester sheets are about 3 mil (i.e., 0.003 inches) in depth. In someembodiments, each intersection of the columns and rows forms a sensingelement (i.e., a sensel), which acts as a variable resistor. In someembodiments, the resistance of each sensel varies inversely with anapplied load. In some embodiments, the sequentially scanning of thesesensels via voltage-divider circuitry enables for 2D mapping of thepressure distribution over a target tissue location (e.g., vertebrae).In some embodiments, traces and spaces are about 1.9 mm in width. Insome embodiments, the center-to-center spacing of rows and columns inthe sensor array is about 1.9 millimeters (mm). In some embodiments, thesensor array has a spatial resolution of about 3.8 mm.

In some embodiments, the center-to-center spacing of rows and columns inthe sensor array is about 0.5 mm to about 5 mm. In some embodiments, thecenter-to-center spacing of rows and columns in the sensor array is atleast about 0.5 mm. In some embodiments, the center-to-center spacing ofrows and columns in the sensor array is at most about 5 mm. In someembodiments, the center-to-center spacing of rows and columns in thesensor array is about 0.5 mm to about 1 mm, about 0.5 mm to about 1.5mm, about 0.5 mm to about 2 mm, about 0.5 mm to about 2.5 mm, about 0.5mm to about 3 mm, about 0.5 mm to about 3.5 mm, about 0.5 mm to about 4mm, about 0.5 mm to about 4.5 mm, about 0.5 mm to about 5 mm, about 1 mmto about 1.5 mm, about 1 mm to about 2 mm, about 1 mm to about 2.5 mm,about 1 mm to about 3 mm, about 1 mm to about 3.5 mm, about 1 mm toabout 4 mm, about 1 mm to about 4.5 mm, about 1 mm to about 5 mm, about1.5 mm to about 2 mm, about 1.5 mm to about 2.5 mm, about 1.5 mm toabout 3 mm, about 1.5 mm to about 3.5 mm, about 1.5 mm to about 4 mm,about 1.5 mm to about 4.5 mm, about 1.5 mm to about 5 mm, about 2 mm toabout 2.5 mm, about 2 mm to about 3 mm, about 2 mm to about 3.5 mm,about 2 mm to about 4 mm, about 2 mm to about 4.5 mm, about 2 mm toabout 5 mm, about 2.5 mm to about 3 mm, about 2.5 mm to about 3.5 mm,about 2.5 mm to about 4 mm, about 2.5 mm to about 4.5 mm, about 2.5 mmto about 5 mm, about 3 mm to about 3.5 mm, about 3 mm to about 4 mm,about 3 mm to about 4.5 mm, about 3 mm to about 5 mm, about 3.5 mm toabout 4 mm, about 3.5 mm to about 4.5 mm, about 3.5 mm to about 5 mm,about 4 mm to about 4.5 mm, about 4 mm to about 5 mm, or about 4.5 mm toabout 5 mm. In some embodiments, the center-to-center spacing of rowsand columns in the sensor array is about 0.5 mm, about 1 mm, about 1.5mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm,about 4.5 mm, or about 5 mm.

In some embodiments, a center-to-center spacing of about 1.9 mmeffectively resolves the lowest extreme of observed interspinous spaces.In some embodiments, the sensor array produces an image with aneffective resolution of an interspinous space of about 3 mm to about 6.5mm. In some embodiments, the sensor array produces an image with aneffective resolution of an interspinous space of at least about 3 mm. Insome embodiments, the sensor array produces an image with an effectiveresolution of an interspinous space of at most about 6.5 mm. In someembodiments, the sensor array produces an image with an effectiveresolution of an interspinous space of about 3 mm to about 3.5 mm, about3 mm to about 4 mm, about 3 mm to about 4.5 mm, about 3 mm to about 5mm, about 3 mm to about 5.5 mm, about 3 mm to about 6 mm, about 3 mm toabout 6.5 mm, about 3.5 mm to about 4 mm, about 3.5 mm to about 4.5 mm,about 3.5 mm to about 5 mm, about 3.5 mm to about 5.5 mm, about 3.5 mmto about 6 mm, about 3.5 mm to about 6.5 mm, about 4 mm to about 4.5 mm,about 4 mm to about 5 mm, about 4 mm to about 5.5 mm, about 4 mm toabout 6 mm, about 4 mm to about 6.5 mm, about 4.5 mm to about 5 mm,about 4.5 mm to about 5.5 mm, about 4.5 mm to about 6 mm, about 4.5 mmto about 6.5 mm, about 5 mm to about 5.5 mm, about 5 mm to about 6 mm,about 5 mm to about 6.5 mm, about 5.5 mm to about 6 mm, about 5.5 mm toabout 6.5 mm, or about 6 mm to about 6.5 mm. In some embodiments, thesensor array produces an image with an effective resolution of aninterspinous space of about 3 mm, about 3.5 mm, about 4 mm, about 4.5mm, about 5 mm, about 5.5 mm, about 6 mm, or about 6.5 mm.

In some embodiments, the pressure rating of the sensor array is about 20psi. In some embodiments, the pressure rating of the sensor array isabout 1 psi to about 150 psi. In some embodiments, the pressure ratingof the sensor array is at least about 1 psi. In some embodiments, thepressure rating of the sensor array is at most about 150 psi. In someembodiments, the pressure rating of the sensor array is about 1 psi toabout 7 psi, about 1 psi to about 25 psi, about 1 psi to about 50 psi,about 1 psi to about 75 psi, about 1 psi to about 100 psi, about 1 psito about 125 psi, about 1 psi to about 150 psi, about 7 psi to about 25psi, about 7 psi to about 50 psi, about 7 psi to about 75 psi, about 7psi to about 100 psi, about 7 psi to about 125 psi, about 7 psi to about150 psi, about 25 psi to about 50 psi, about 25 psi to about 75 psi,about 25 psi to about 100 psi, about 25 psi to about 125 psi, about 25psi to about 150 psi, about 50 psi to about 75 psi, about 50 psi toabout 100 psi, about 50 psi to about 125 psi, about 50 psi to about 150psi, about 75 psi to about 100 psi, about 75 psi to about 125 psi, about75 psi to about 150 psi, about 100 psi to about 125 psi, about 100 psito about 150 psi, or about 125 psi to about 150 psi. In someembodiments, the pressure rating of the sensor array is about 1 psi,about 7 psi, about 25 psi, about 50 psi, about 75 psi, about 100 psi,about 125 psi, or about 150 psi. In some embodiments, a pressure ratingof 20 psi effectively resolves a target tissue location (e.g., aninterspinous space). In some embodiments, a pressure rating of about 20psi effectively resolves bony landmarks as deep as about 60 mm. In someembodiments, a depth of about 60 mm corresponds to a tissue depth of anobese patient having a body mass index (BMI) of about 40 kg/m².

In some embodiments, the sensor array comprises about 38 rows and about9 columns, which corresponds to an active sensing area comprising about7.05 mm in length by about 15.2 mm in width. In some embodiments, thesensor array comprises an active sensing area with a width of about 5 mmto about 30 mm. In some embodiments, the sensor array comprises anactive sensing area with a width of at least about 5 mm. In someembodiments, the sensor array comprises an active sensing area with awidth of at most about 30 mm. In some embodiments, the sensor arraycomprises an active sensing area with a width of about 5 mm to about 6mm, about 5 mm to about 7 mm, about 5 mm to about 8 mm, about 5 mm toabout 9 mm, about 5 mm to about 10 mm, about 5 mm to about 15 mm, about5 mm to about 20 mm, about 5 mm to about 25 mm, about 5 mm to about 30mm, about 6 mm to about 7 mm, about 6 mm to about 8 mm, about 6 mm toabout 9 mm, about 6 mm to about 10 mm, about 6 mm to about 15 mm, about6 mm to about 20 mm, about 6 mm to about 25 mm, about 6 mm to about 30mm, about 7 mm to about 8 mm, about 7 mm to about 9 mm, about 7 mm toabout 10 mm, about 7 mm to about 15 mm, about 7 mm to about 20 mm, about7 mm to about 25 mm, about 7 mm to about 30 mm, about 8 mm to about 9mm, about 8 mm to about 10 mm, about 8 mm to about 15 mm, about 8 mm toabout 20 mm, about 8 mm to about 25 mm, about 8 mm to about 30 mm, about9 mm to about 10 mm, about 9 mm to about 15 mm, about 9 mm to about 20mm, about 9 mm to about 25 mm, about 9 mm to about 30 mm, about 10 mm toabout 15 mm, about 10 mm to about 20 mm, about 10 mm to about 25 mm,about 10 mm to about 30 mm, about 15 mm to about 20 mm, about 15 mm toabout 25 mm, about 15 mm to about 30 mm, about 20 mm to about 25 mm,about 20 mm to about 30 mm, or about 25 mm to about 30 mm. In someembodiments, the sensor array comprises an active sensing area with awidth of about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm,about 10 mm, about 15 mm, about 20 mm, about 25 mm, or about 30 mm.

In some embodiments, the sensor array comprises an active sensing areawith a length of about 30 mm to about 90 mm. In some embodiments, thesensor array comprises an active sensing area with a length of at leastabout 30 mm. In some embodiments, the sensor array comprises an activesensing area with a length of at most about 90 mm. In some embodiments,the sensor array comprises an active sensing area with a length of about30 mm to about 35 mm, about 30 mm to about 40 mm, about 30 mm to about45 mm, about 30 mm to about 50 mm, about 30 mm to about 55 mm, about 30mm to about 60 mm, about 30 mm to about 65 mm, about 30 mm to about 70mm, about 30 mm to about 75 mm, about 30 mm to about 80 mm, about 30 mmto about 90 mm, about 35 mm to about 40 mm, about 35 mm to about 45 mm,about 35 mm to about 50 mm, about 35 mm to about 55 mm, about 35 mm toabout 60 mm, about 35 mm to about 65 mm, about 35 mm to about 70 mm,about 35 mm to about 75 mm, about 35 mm to about 80 mm, about 35 mm toabout 90 mm, about 40 mm to about 45 mm, about 40 mm to about 50 mm,about 40 mm to about 55 mm, about 40 mm to about 60 mm, about 40 mm toabout 65 mm, about 40 mm to about 70 mm, about 40 mm to about 75 mm,about 40 mm to about 80 mm, about 40 mm to about 90 mm, about 45 mm toabout 50 mm, about 45 mm to about 55 mm, about 45 mm to about 60 mm,about 45 mm to about 65 mm, about 45 mm to about 70 mm, about 45 mm toabout 75 mm, about 45 mm to about 80 mm, about 45 mm to about 90 mm,about 50 mm to about 55 mm, about 50 mm to about 60 mm, about 50 mm toabout 65 mm, about 50 mm to about 70 mm, about 50 mm to about 75 mm,about 50 mm to about 80 mm, about 50 mm to about 90 mm, about 55 mm toabout 60 mm, about 55 mm to about 65 mm, about 55 mm to about 70 mm,about 55 mm to about 75 mm, about 55 mm to about 80 mm, about 55 mm toabout 90 mm, about 60 mm to about 65 mm, about 60 mm to about 70 mm,about 60 mm to about 75 mm, about 60 mm to about 80 mm, about 60 mm toabout 90 mm, about 65 mm to about 70 mm, about 65 mm to about 75 mm,about 65 mm to about 80 mm, about 65 mm to about 90 mm, about 70 mm toabout 75 mm, about 70 mm to about 80 mm, about 70 mm to about 90 mm,about 75 mm to about 80 mm, about 75 mm to about 90 mm, or about 80 mmto about 90 mm. In some embodiments, the sensor array comprises anactive sensing area with a length of about 30 mm, about 35 mm, about 40mm, about 45 mm, about 50 mm, about 55 mm, about 60 mm, about 65 mm,about 70 mm, about 75 mm, about 80 mm, or about 90 mm.

In some embodiments, the tactile sensing device is a rocker tactilesensor device 1800 comprising a removable handle 68, as shown in FIGS.18A-C. In some embodiments, the removable handle is a power grip handle.In some embodiments, the removable handle is similar to the power griphandle 68 shown in FIG. 11. In some embodiments, the removable handle isremoved to expose the needle guide 2. In some embodiments, the removablehandle comprises a first post and a second post that are inserted into afirst opening and a second opening in the top surface of the sensorapplicator or main housing frame 19 of the tactile sensing device 1800.In some embodiments, the handle and the main housing frame 19 arereversibly coupled to each other via a mechanism that includes anaudible indication, such as, but not limited to, a clicking noise. Insome embodiments, the handle has a handle release button 27, as shown inFIGS. 18A-C. In some embodiments, the handle release button 27 islocated at the posterior or anterior end of the handle. In someembodiments, the handle release button 27 is pushed to disengage thehandle from the curved sensor applicator 13 or main housing frame 19. Insome embodiments, the handle is comprised of a two-part housing. In someembodiments, the posts of the handle comprise a skirt that secures theposts in the openings after insertion.

In some embodiments, the tactile sensing device is a rocker tactilesensing device 2400 comprising a reusable user interface (UI) module 1.In some embodiments, the UI module 1 is part of a main housing frame 19.In some embodiments the UI module is comprised of a two-part housing. Insome embodiments the UI module has a back plate for access toelectronics. In some embodiments, the UI module is assembled with themain housing frame 19. In some embodiments, the UI module 1 is anon-sterile, non-patient-contacting part, to be made of medical-grade,injection-molded plastic. In some embodiments, the main housing frame 19comprises hubs for UI module attachment at the top and bottom when thedevice is viewed from the top to facilitate use in right- andleft-handed users. In some embodiments, the UI module 1 comprises aprinted circuit board assembly (PCBA). In some embodiments, the PCBAserves as the motherboard of the system of the tactile sensing device.In some embodiments, the PCBA comprises a microprocessor. In someembodiments, the PCBA interfaces to the sensor breakout board, displaymodule, external sensors, and user-input mechanisms. In someembodiments, the PCBA comprises the fusing, charging, and protectioncircuitry for the rechargeable battery. In some embodiments, the PCBAprocesses and displays pressure sensor data. In some embodiments, thePCBA handles interrupts, such as a physical or touchscreen menu buttonpress and physical or touchscreen refresh button press. In someembodiments, a sample runtime task for live imaging (about 50milliseconds (ms)) comprises data capture, data analysis, error checks,frame drawing, and frame display. In some embodiments, the PCBAcomprises circuitry to support adjustment of maximum sensor pressurebetween a factor of 1/7 and a factor of 3 of the sensor's pressurerating. In some embodiments, sensitivity is adjusted via a dial orexternal buttons, or a touchscreen display. In some embodiments drivevoltage is automatically adjusted based on an equilibration file. Insome embodiments, the PCBA comprises sensors and circuitry to trackdevice orientation and trigger alerts to device movement during rocking.In some embodiments, the UI module is powered on by a switch.

In some embodiments, the tactile sensing device comprises a sensorbreakout board (not shown in the figures). In some embodiments, thesensor breakout board comprises minimal electronics that are disposable.In some embodiments, the sensor breakout board is configured to connectthe sensor driver and acquisition circuitry from the UI module to thesensor array. In some embodiments, the sensor breakout board comprises azero insertion force (ZIF) connector for sensor array connection. Insome embodiments, the sensor breakout board comprises an analogmultiplexer (MUX) and a bit shifter to support scanning and output. Insome embodiments, position sensors to track device movement arecomprised in the disposable breakout board. In some embodiments, the UImodule is powered on upon connection to the breakout board.

In some embodiments, the UI module comprises a display screen. In someembodiments, the display screen is a touchscreen. In some embodiments,the display screen has an adjustable angle. In some embodiments, thedisplay screen is a full-color LCD display. In some embodiments, thedisplay screen is connected to the PCBA and mechanically integrated inthe anterior surface of the housing of the module, to allow for outputvisualization. In some embodiments, the tactile sensing devicewirelessly interfaces with an external display, such as a tablet orcomputer. In some embodiments, the display is collapsed to reducetactile sensing device footprint.

In some embodiments, the tactile sensing device is a rocker tactilesensing device 2400 comprising a sleeve 80. In some embodiments, thesleeve is a single-component part that is sterile. In some embodiments,the sleeve shrouds the reusable UI module during use. In someembodiments, the sleeve is made of medical-grade polyethyleneterephthalate glycol-modified (PETG). In some embodiments, the sleeve isvacuum-formed to a mold of the reusable UI module. In some embodiments,the sleeve comprises a low-reflectivity, transparent component over thedisplay area. In some embodiments, the sleeve has openings foruser-input buttons.

In some embodiments, the UI module comprises a battery. In someembodiments, the battery is a rechargeable battery. In some embodiments,the rechargeable battery interfaces with the PCBA. In some embodiments,the tactile sensing device comprises a battery indicator. In someembodiments, the battery indicator is a charging indicator. In someembodiments, the charging indicator alerts the user of a low battery. Insome embodiments, the charging indicator alerts the user of the amountof battery charged during the charging process. In some embodiments, thebattery indicator is on-screen. In some embodiments, the batteryindicator is an LED. In some embodiments, the device is powered via USBconnection to a computer.

In some embodiments, the rechargeable battery located within the tactilesensing device is charged using a reusable charging station (not shownin the figures). In some embodiments, the charging unit comprisesstandard electronics, including electrical contacts for mating with thecomputing unit (i.e., with PCBA). In some embodiments, the chargingstation is housed in a two-part injection molded plastic. In someembodiments, the charging station comprises a charging indicator. Insome embodiments, the charging station employs induction charging.

FIGS. 18-21 show embodiments of a tactile sensing device 2400 comprisinga rocker design, referred to herein as rocker tactile sensing devices.In some embodiments, the rocker tactile sensing device 1800 comprises aUI module 1, a power grip handle 68, and a main housing frame 19. Insome embodiments, the UI module 1 comprises a display screen 4, apressure map 6, and a UI module connector 9. In some embodiments, asleeve 80 shrouds the UI module 1. In some embodiments, the main housingframe 19 comprises a first handle opening 5 a and a second handleopening 5 b configured to receive the power grip handle 68. In someembodiments, the handle and the main housing frame are reversiblycoupled to each other via a mechanism that includes an audibleindication, such as, but not limited to, a clicking noise. In someembodiments, the power grip handle 68 comprises a first handle notch 3 aand a second handle notch 3 b. In some embodiments, the power griphandle 68 comprises a handle skirt 11. In some embodiments, the handleskirt 11 is configured to secure the power grip handle 68 once insertedinto the first handle opening 5 a and the second handle opening 5 b. Insome embodiments, the main housing frame 19 comprises a UI module slot 7configured to receive the UI module connector 9. In some embodiments,the UI module 1 is powered upon connection with the housing comprisingthe sensor platform and array. In some embodiments, the UI module ispowered by a switch.

As shown in FIGS. 18B, the tactile sensing device comprising the rockerdesign comprises a curved sensor applicator 13. In some embodiments, thecurved sensor applicator comprises the sensor array. In someembodiments, the sensor array is adhered to the surface of the curvedsensor applicator. In some embodiments, the curved sensor platform 13and the sensor array comprise a slot to facilitate needle insertion andtactile sensing device removal. As shown in FIG. 18A, the tactilesensing device comprises a needle guide. In some embodiments, the needleguide is a slot 38. In some embodiments, the slot 38 comprises a firstneedle guide wall 131 a and a second needle guide wall 131 b. In someembodiments, the needle guide comprises a slot opening 38 a and a slotterminus 38 b.

FIGS. 20A-E show the workflow of how a user utilizes the tactile sensingdevice 1800 comprising the rocker design, alternatively referred to arocker tactile sensing device, when imaging a target tissue location ofa patient. In some embodiments, the user inserts the handle 68 into themain housing frame 19 via the handle openings. Next, in someembodiments, the user visually locates the general area of the targettissue location (e.g., spinous processes). Next, in some embodiments,the user places the tactile sensing device on the skin surface of thepatient, ensuring the midline of the device aligns with the targettissue location (i.e., the spine). FIG. 20A shows the user 28 applying aconstant downward pressure on the power grip handle 68, through thesensor array, and onto the skin surface of the patient. Furthermore,FIG. 20A illustrates how the user 28 obtains a first image of the targettissue location when exerting a forward rocking motion of the devicewhile pressing against the skin surface of the patient 15. In someembodiments, the sleeve 80 is used as a sterile barrier between thepatient 15 and the reusable UI module 1.

FIG. 20B shows how the user 28 obtains a second image of the targettissue location when exerting a backward rocking motion of the devicewhile pressing against the skin surface of the patient 15. In someembodiments, the user partially images the target tissue location whenexerting either a forward or backward rocking motion of the device whilepressing it against the patient. In some embodiments, a complete imageof the target tissue location is acquired once the user exerts both aforward or backward rocking motion of the device while pressing itagainst the patient. In some embodiments, the user rocks the tactilesensing device forward to its maximum position and subsequently rocksthe tactile sensing device backward to the maximum downward position,and then back to center in order to fully image the target tissuelocation (e.g., spinous processes). In some embodiments, the usercontinues to rock the tactile sensing device as necessary until thedisplay screen displays the hotspots of the target tissue location(e.g., the spinous processes) and the midline. In some embodiments, thedisplay screen displays a line corresponding to the midline. In someembodiments, the display screen displays a crosshair corresponding tolocation of the needle guide relative to the spine. In some embodiments,the display screen displays an arrow indicating to the user thedirection in which the tactile sensing device needs to be moved in orderto localize the target tissue location. In some embodiments, the userrefreshes the device output and starts the imaging process again atanother location along the spine.

In some embodiments, once the complete image of the target tissuelocation is acquired, the tactile sensing device prompts the user whenthe needle guide is at correct location, as shown in FIG. 20C. In someembodiments, upon correct alignment of the needle guide, the user 28detaches the power grip handle 68 by pulling the handle up in order torelease it from the main housing frame 19, as shown in FIG. 20D. In someembodiments, the handle is detached by pressing at least one button thatreleases the handle from the main housing frame 19. Next, in someembodiments, the user proceeds to insert the needle or marking tool intothe needle guide. In some embodiments, the needle guide allows for acertain degree of angular movement that enables the user to pinpoint theexact needle insertion position required. In some embodiments, thetactile sensing device is removed after needle insertion by sliding thedevice leftward along the skin surface. In some embodiments, the tactilesensing device comprises a needle retention clip 17, as shown in FIG.20E. The needle retention clip 17 is configured to keep the needle 14fixed in place. In some embodiments, the needle retention clip isdisengaged to allow release the needle from the device in order to slidethe device off the skin surface.

Slider Tactile Sensing Device

In some embodiments, the tactile sensing device is a slider tactilesensing device 2100, as shown in the embodiments depicted in FIGS.21A-B, 22A-C, 23A-B, 24A-C, 25A-B, and 26A-D alternatively referred to atactile sensing device including a slider design herein. In embodimentsof the tactile sensing device that are slider tactile sensing devices,the devices include aspects and functionality of the tactile sensingdevices described elsewhere herein with the sensor array being movablerelative to the body of the device and that uses and includes historicaland real time image visualization thereby requiring a smaller sensorarray to build an image for display of the anatomy of a subject ascompared to a non-sliding tactile sensing device, and as compared to arocker tactile sensing device sensor array.

FIG. 21A shows an isometric view of the slider tactile sensing device2100. In some embodiments, the slider tactile sensing device 2100comprises a scanning knob 21. In some embodiments, the slider tactilesensing device 2100 comprises a scanhead subassembly 23. In someembodiments, the scanning knob 21 is configured to enable the user totranslate the carriage-scanhead subassembly along a distance (e.g.,along the vertebrae of a patient). In some embodiments, the scanningknob 21 is configured to enable the user to press the sensor array ontothe surface of the skin of the patient. In some embodiments, thescanning knob 21 is configured to lock the scanhead 33 in place once atarget tissue insertion site is identified. In some embodiments, thescanning knob 21 is supplied as a separate component.

In some embodiments, the scanhead 33 allows the sensor array to betranslated over a distance (e.g., along a 3 inch distance along thevertebrae). In some embodiments, the scanhead 33 is translated over adistance of about 0.5 inches (in.) to about 10 in. In some embodiments,the scanhead 33 is translated over a distance of at least about 0.5 in.In some embodiments, the scanhead 33 is translated over a distance of atmost about 10 in. In some embodiments, the scanhead 33 is translatedover a distance of about 0.5 in. to about 1 in., about 0.5 in. to about2 in., about 0.5 in. to about 3 in., about 0.5 in. to about 4 in., about0.5 in. to about 5 in., about 0.5 in. to about 6 in., about 0.5 in. toabout 7 in., about 0.5 in. to about 8 in., about 0.5 in. to about 9 in.,about 0.5 in. to about 10 in., about 1 in. to about 2 in., about 1 in.to about 3 in., about 1 in. to about 4 in., about 1 in. to about 5 in.,about 1 in. to about 6 in., about 1 in. to about 7 in., about 1 in. toabout 8 in., about 1 in. to about 9 in., about 1 in. to about 10 in.,about 2 in. to about 3 in., about 2 in. to about 4 in., about 2 in. toabout 5 in., about 2 in. to about 6 in., about 2 in. to about 7 in.,about 2 in. to about 8 in., about 2 in. to about 9 in., about 2 in. toabout 10 in., about 3 in. to about 4 in., about 3 in. to about 5 in.,about 3 in. to about 6 in., about 3 in. to about 7 in., about 3 in. toabout 8 in., about 3 in. to about 9 in., about 3 in. to about 10 in.,about 4 in. to about 5 in., about 4 in. to about 6 in., about 4 in. toabout 7 in., about 4 in. to about 8 in., about 4 in. to about 9 in.,about 4 in. to about 10 in., about 5 in. to about 6 in., about 5 in. toabout 7 in., about 5 in. to about 8 in., about 5 in. to about 9 in.,about 5 in. to about 10 in., about 6 in. to about 7 in., about 6 in. toabout 8 in., about 6 in. to about 9 in., about 6 in. to about 10 in.,about 7 in. to about 8 in., about 7 in. to about 9 in., about 7 in. toabout 10 in., about 8 in. to about 9 in., about 8 in. to about 10 in.,or about 9 in. to about 10 in.. In some embodiments, the scanhead 33 istranslated over a distance of about 0.5 in., about 1 in., about 2 in.,about 3 in., about 4 in., about 5 in., about 6 in., about 7 in., about 8in., about 9 in., or about 10 in.

In some embodiments, the surface of the distal end with respect to theuser (i.e., the bottom surface) of the scanhead subassembly 23 comprisesthe sensor array. In some embodiments, the scanhead 33 is configured toreceive the scanning knob 21. In some embodiments, the sensor array (notshown in FIGS. 21A-B) is mounted on the bottom surface of the scanhead33. In some embodiments, the scanhead 33 has a size and curvaturedesigned to mimic palpation and optimize vertebral resolution. As shownin FIG. 21A, the slider tactile sensing device 2100 comprises a gripfeature 76. In some embodiments, the grip feature 76 is the outerportion of the main housing frame 19. In some embodiments, the user usesthe grip feature 76 to press the device against the patient. In someembodiments, the grip feature 76 is any of the previously described gripfeatures.

In some embodiments, the slider device comprises a main housing frame19. In some embodiments, the main housing frame 19 comprises anindicator for the midline of the tactile sensing device to facilitatealignment with the spine. In some embodiments the indicator for themidline of the tactile sensing device is a needle alignment guide 36. Insome embodiments, the indicator is a colored notch. In some embodiments,the main housing frame 19 is reusable. In some embodiments, the mainhousing frame 19 is disposable. In some embodiments, the main housingframe 19 is made of medical-grade, injection-molded plastic. In someembodiments, the main housing frame 19 is comprised of two parts. Insome embodiments, the main housing frame 19 comprises apatient-attachment mechanism on the bottom surface. In some embodimentsthe patient-attachment feature employs a vacuum, an adhesive, or a beltmechanism. In some embodiments, the patient-contacting surface of themain housing frame 19 is curved. In some embodiments, thepatient-contacting surface of the main housing frame 19 has a downwardconcave curvature to conform to one or more vertebrae in flexion. Insome embodiments, the patient-contacting surface of the main housingframe 19 has an upward concave curvature to conform to the tissuebetween the thoracolumbar fascia. In some embodiments, thepatient-contacting surface of the main housing frame 19 has an M-shapedcurvature to optimize conformance in the mediolateral direction. In someembodiments, the main housing frame 19 comprises a grip area for theuser's non-dominant hand. In some embodiments, the grip area is on theleft side of the main housing frame 19 when viewed from the front. Insome embodiments, the grip area is rounded. In some embodiments the griparea comprises multiple materials. In some embodiments, the grip areacomprises an undercut to improve purchase. In some embodiments, the griparea is a removable palm pad that is assembled with the main housingframe 19. In some embodiments, removable palm pads are available indifferent sizes and grips.

FIG. 21B shows a cut away view of the slider tactile sensing device 2100with no force being applied onto the proximal end (with respect to theuser) of the scanning knob 21. In contrast, FIG. 21C shows a cut awayview of the slider tactile sensing device 2100 while a force is beingapplied onto the proximal end (with respect to the user) of the scanningknob 21. In other words, FIG. 21C shows the tactile sensing device 2100as a user (not shown in FIGS. 21A-B) presses down onto the scanning knob21 and depresses the entire scanhead subassembly 23 (e.g., onto thesurface of the skin of a patient). In some embodiments, the scanningknob 21 is reversibly attached to the tactile sensing device 2100 via afirst release clip 43 a and a second release clip 43 b at the top of thescanhead 33, as shown in FIG. 21B. In some embodiments, the firstrelease clip 43 a comprises a first foot 63 a. In some embodiments, thefirst release clip 43 a comprises a second foot 63 b. In someembodiments, the slider tactile sensing device 2100 comprises a firstledge 65 a. In some embodiments, the slider tactile sensing device 2100comprises a second ledge 65 b. In some embodiments, the first ledge 65 ais configured to receive the first foot 63 a. Likewise, in someembodiments, the second ledge 65 b is configured to receive the secondfoot 63 b.

In some embodiments, the slider tactile sensing device 2100 comprises afirst retention clip spring 67 a. In some embodiments, the slidertactile sensing device 2100 comprises a second retention clip spring 67b. In some embodiments, the scanning knob 21 comprises a first scanningknob notch 69 a and a second scanning knob notch 69 b, as shown in FIG.21B. In some embodiments, the first scanning knob notch 69 a isconfigured to receive the first retention clip spring 67 a and thesecond retention clip spring 67 b. In some embodiments, the firstretention clip 43 a comprises a first indentation that is configured toreceive the first retention clip spring 67 a. Similarly, in someembodiments, the second retention clip 43 b comprises a secondindentation that is configured to receive the second retention clipspring 67 b. Thus, in some embodiments, the first retention clip spring67 a is positioned between the scanning knob and the first retentionclip 43 a and the second retention clip spring 67 b is positionedbetween the scanning knob 21 and the second retention clip 43 b, asillustrated in FIG. 21B. In some embodiments, the first retention clip43 a and the second retention clip spring 67 b have a compressed stateand an uncompressed state. In some embodiments, the first retention clip43 a and the second retention clip spring 67 b are in a biased,uncompressed position or in an unbiased, compressed position.

In some embodiments, the first retention clip spring 67 a and the secondretention clip 67 b serve as a locking mechanism of the scanning knob21. FIG. 21C illustrates the scanning knob 21 in a locked state orposition. In some embodiments, the first foot 63 a is inserted into thefirst ledge 65 a and the second foot 63 b is inserted into the secondledge 65 b when the scanning knob 21 is in a locked position (i.e., whenthe scanning knob 21 is attached to the tactile sensing device 2100), asshown in FIG. 21C. In some embodiments, the user pinches the firstretention clip 43 a and the second retention clip 43 b in order todisengage the first foot 63 a from the first ledge 65 a and the secondfoot 63 b from the second ledge 65 b. FIG. 21B illustrates the unlockedstate of the scanning knob 21. In some embodiments, when the scanningknob 21 is in the unlocked state, the first retention clip spring 67 ais in an unbiased, compressed position, which causes the first foot 63 ato point laterally away and disengage from the first ledge 65 a.Similarly, in some embodiments, when the scanning knob 21 is in theunlocked state, the second retention clip spring 67 b is in an unbiased,compressed position, which causes the second foot 63 b to pointlaterally away and disengage from the second ledge 65 b.

FIG. 21B illustrates the slider tactile sensing device 2100 comprising ascanhead subassembly 23 that is in a non-depressed state. On the otherhand, FIG. 21C shows the slider tactile sensing device 2100 comprising ascanhead subassembly 23 that is in a depressed state. In other words,FIG. 21C shows the scanhead subassembly 23 at a lower position or depthalong the X-axis compared to the initial position or depth along theX-axis of the scanhead subassembly 23 that is shown in FIG. 21B. In someembodiments, the scanhead subassembly 23 comprises a first spring 71 aand a second spring 71 b. In some embodiments, the scanhead subassembly23 comprises an indentation located distally from and underneath thefirst ledge 65 a, that is configured to receive the first spring 71 a.Similarly, in some embodiments, the scanhead subassembly 23 comprises afirst indentation located distally from and underneath the second ledge65 b, that is configured to receive the second spring 71 b. In someembodiments, the first spring 71 a is located distally from andunderneath the first ledge 65 a. In some embodiments, the second spring71 b is located distally from and underneath the second ledge 65 b. Insome embodiments, the first spring 71 a is positioned within the firstindentation of the scanhead subassembly 23. In some embodiments, thesecond spring 71 b is positioned within the second indentation of thescanhead subassembly 23.

In some embodiments, the user applies a force on or presses down on thescanning knob 21 in order to depress the scanhead subassembly 23. Insome embodiments, the user applies a force or presses down on thescanning knob 21 in order to change the position of the scanheadsubassembly 23 to a lower position or depth. In some embodiments, thefirst spring 71 a and the second spring 71 b change from a biased,uncompressed position to an unbiased, compressed position when the userapplies a force on or presses down on the scanning knob 21. FIG. 21Billustrates the first spring 71 a and the second spring 71 b in abiased, uncompressed position. Meanwhile, FIG. 21C illustrates the firstspring 71 a and the second spring 71 b in an unbiased, compressedposition.

In some embodiments, the first spring 71 a and the second spring 71 bare located directly below the first ledge 65 a and the second ledge 65b, respectively, when they are in an unbiased, compressed position(i.e., when the user applies a force on or presses down on the scanningknob 21), as shown in FIG. 21C. In some embodiments, the slider tactilesensing device 2100 comprises a third ledge 65 c and a fourth ledge 65d. In some embodiments, the third ledge 65 c is located distally awayand below the first ledge 65 a, as shown in FIG. 21C. In someembodiments, the fourth ledge 65 d is located distally away and belowthe second ledge 65 b, as shown in FIG. 21C. In some embodiments, thefirst spring 71 a is located in between the first ledge 65 a and thethird ledge 65 c when the first spring 71 a is in an unbiased,compressed position (i.e., when the user applies a force on or pressesdown on the scanning knob 21). In some embodiments, the second spring 71b is located in between the second ledge 65 b and the fourth ledge 65 dwhen the second spring 71 b is in an unbiased, compressed position(i.e., when the user applies a force on or presses down on the scanningknob 21).

In alternative embodiments, not illustrated in the figures, the firstspring 71 a and the second spring 71 b are located directly within thethird ledge 65 c and the fourth ledge 65 d, respectively, when they arein an unbiased, compressed position. In other words, in alternativeembodiments, the first spring 71 a and the second spring 71 b aredisplaced into the third ledge 65 c and the fourth ledge 65 d,respectively, when the user applies a force on or presses down on thescanning knob 21. In some embodiments, the first spring 71 a and thesecond spring 71 b are located in a more proximal position (with respectto the user) than the third ledge 65 c and the fourth ledge 65 d,respectively, when they are in an unbiased, compressed position (i.e.,when the user applies a force on or presses down on the scanning knob21), as shown in FIG. 21C.

FIG. 21C illustrates a depth 73 (along the X-axis) of the scanheadsubassembly. In some embodiments, the user controls the depth 73 of thescanhead subassembly 23 along the X-axis by varying the amount of forcethat she or he applies to the scanning knob 21. In some embodiments, thefirst spring 71 a and the second spring 71 b determine a maximum depth73 (along the X-axis) of the scanhead subassembly 23. In someembodiments, the maximum depth 73 (along the X-axis) of the scanheadsubassembly 23 occurs when the first spring 71 a and the second spring71 b are at a fully unbiased, compressed position. In some embodiments,the depth 73 of the scanhead subassembly ranges from about 0 centimeters(cm) to about 10 cm. In some embodiments, the depth 73 of the scanheadsubassembly ranges from at least about 0 cm. In some embodiments, thedepth 73 of the scanhead subassembly ranges from at most about 10 cm. Insome embodiments, the depth 73 of the scanhead subassembly ranges fromabout 0 cm to about 1 cm, about 0 cm to about 2 cm, about 0 cm to about3 cm, about 0 cm to about 4 cm, about 0 cm to about 5 cm, about 0 cm toabout 6 cm, about 0 cm to about 7 cm, about 0 cm to about 8 cm, about 0cm to about 9 cm, about 0 cm to about 10 cm, about 1 cm to about 2 cm,about 1 cm to about 3 cm, about 1 cm to about 4 cm, about 1 cm to about5 cm, about 1 cm to about 6 cm, about 1 cm to about 7 cm, about 1 cm toabout 8 cm, about 1 cm to about 9 cm, about 1 cm to about 10 cm, about 2cm to about 3 cm, about 2 cm to about 4 cm, about 2 cm to about 5 cm,about 2 cm to about 6 cm, about 2 cm to about 7 cm, about 2 cm to about8 cm, about 2 cm to about 9 cm, about 2 cm to about 10 cm, about 3 cm toabout 4 cm, about 3 cm to about 5 cm, about 3 cm to about 6 cm, about 3cm to about 7 cm, about 3 cm to about 8 cm, about 3 cm to about 9 cm,about 3 cm to about 10 cm, about 4 cm to about 5 cm, about 4 cm to about6 cm, about 4 cm to about 7 cm, about 4 cm to about 8 cm, about 4 cm toabout 9 cm, about 4 cm to about 10 cm, about 5 cm to about 6 cm, about 5cm to about 7 cm, about 5 cm to about 8 cm, about 5 cm to about 9 cm,about 5 cm to about 10 cm, about 6 cm to about 7 cm, about 6 cm to about8 cm, about 6 cm to about 9 cm, about 6 cm to about 10 cm, about 7 cm toabout 8 cm, about 7 cm to about 9 cm, about 7 cm to about 10 cm, about 8cm to about 9 cm, about 8 cm to about 10 cm, or about 9 cm to about 10cm. In some embodiments, the depth 73 of the scanhead subassembly rangesfrom about 0 cm, about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, or about 10 cm.Alternatively, in other embodiments not illustrated in the drawings, thescanning head 21 has a second locking mechanism to lock the scanningknob 21 at various depths along the X-axis. For example, in someembodiments, the user pinches the first retention clip 43 a and thesecond retention clip 43 b and disengages the first foot 63 a and thesecond foot 63 b, the user is able to depress the entire scanheadsubassembly 23 along the X-axis by pressing down on the scanning knob 21while maintaining both retention clips pinched. In some embodiments, theuser further locks the scanhead subassembly 23 in a depressed state(i.e., at a determined depth) by releasing the first retention clip 43 aand the second retention clip 43 b and allowing the first foot 63 a toinsert into a third ledge (not shown in the figures) and allowing thesecond foot 63 b to insert into a fourth ledge (not shown in thefigures). In some embodiments, the scanhead assembly 23 comprises two ormore ledges that enable the user to lock the scanhead assembly 23 at apredetermined depth. In some embodiments, the scanhead assembly 23comprises about 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, ormore ledges.

FIGS. 22A-C show how the scanhead subassembly 23 attaches to the slidertactile sensing device 2100. FIG. 22A illustrates an isometric view ofthe scanhead subassembly 23. In some embodiments, the scanheadsubassembly 23 comprises a scanhead 33, a scanning knob 21, and acarriage 35. In some embodiments, the slider tactile sensing device 2100comprises a scanning track 45 and a locking rack 75. In someembodiments, the slider design comprises a scanning track 45. In someembodiments, the scanning track 45 is part of the main housing frame 19.In some embodiments the scanning track 45 is a removable part that isassembled with the main housing frame 19. In some embodiments, thescanning track 45 comprises a track 45 that is configured to translatethe scanhead 33 along the skin surface of the patient. In someembodiments, the scanning track 45 is configured to translate thescanhead 33 along the direction of the arrows shown in FIG. 22A. In someembodiments, the scanning track 45 is configured to receive the carriage35. In some embodiments, the carriage 35 sits on the scanning track 45.In some embodiments, the carriage 35 glides over the scanning track 45.In some embodiments, the carriage 35 snaps onto the scanning track 45.In some embodiments, the scanning track 45 comprises grooves that allowa scanhead to be locked into place after an insertion site isidentified. In some embodiments, the subassembly comprises a lockingrack 75 and a release button (not shown in the figures).

In some embodiments, the scanning track 45 allows for about 2.75 inchesto about 3 inches of scanhead travel. In some embodiments, the length ofthe scanning track is based on the distance between the top and bottomof consecutive spinous processes. In some embodiments, the scanningtrack 45 allows for a scanhead travel distance of about 1 cm to about 10cm. In some embodiments, the scanning track 45 allows for a scanheadtravel distance of at least about 1 cm. In some embodiments, thescanning track 45 allows for a scanhead travel distance of at most about10 cm. In some embodiments, the scanning track 45 allows for a scanheadtravel distance of about 1 cm to about 2 cm, about 1 cm to about 3 cm,about 1 cm to about 4 cm, about 1 cm to about 5 cm, about 1 cm to about6 cm, about 1 cm to about 7 cm, about 1 cm to about 8 cm, about 1 cm toabout 9 cm, about 1 cm to about 10 cm, about 2 cm to about 3 cm, about 2cm to about 4 cm, about 2 cm to about 5 cm, about 2 cm to about 6 cm,about 2 cm to about 7 cm, about 2 cm to about 8 cm, about 2 cm to about9 cm, about 2 cm to about 10 cm, about 3 cm to about 4 cm, about 3 cm toabout 5 cm, about 3 cm to about 6 cm, about 3 cm to about 7 cm, about 3cm to about 8 cm, about 3 cm to about 9 cm, about 3 cm to about 10 cm,about 4 cm to about 5 cm, about 4 cm to about 6 cm, about 4 cm to about7 cm, about 4 cm to about 8 cm, about 4 cm to about 9 cm, about 4 cm toabout 10 cm, about 5 cm to about 6 cm, about 5 cm to about 7 cm, about 5cm to about 8 cm, about 5 cm to about 9 cm, about 5 cm to about 10 cm,about 6 cm to about 7 cm, about 6 cm to about 8 cm, about 6 cm to about9 cm, about 6 cm to about 10 cm, about 7 cm to about 8 cm, about 7 cm toabout 9 cm, about 7 cm to about 10 cm, about 8 cm to about 9 cm, about 8cm to about 10 cm, or about 9 cm to about 10 cm. In some embodiments,the scanning track 45 allows for a scanhead travel distance of about 1cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7cm, about 8 cm, about 9 cm, or about 10 cm.

FIG. 22B shows a posterior view of the scanhead subassembly 23 whilebeing attached to the main housing frame 19 of the slider tactilesensing device 2100. Furthermore, FIG. 22C is a cutaway illustration ofthis same posterior view that further shows the locking mechanismbetween the scanhead subassembly 23 and the main housing frame 19 of theslider tactile sensing device 2100. In some embodiments, the scanhead 33comprises a locking insert 77. In some embodiments, the locking insert77 comprises a sawtooth edge. In some embodiments, the sawtooth edge ofthe locking insert 77 projects downwards. In some embodiments, thelocking insert 77 is protrudes from the posterior side of the scanhead33. In some embodiments, the locking insert 77 is configured to couplewith the locking rack 75. In some embodiments, the locking rack 75comprises a sawtooth edge. In some embodiments, the locking rack 75 is asawtooth rack. In some embodiments, the sawtooth edge of the lockingrack 75 projects upwards. In some embodiments, the locking insert 77 andthe locking rack 75 comprise sawtooth projections that have a samepitch. In some embodiments, the locking insert 77 and the locking rack75 are configured to lock in place when coupled.

In some embodiments, the locking insert 77 and the locking rack 75 serveas a locking mechanism for the scanhead subassembly 23. In someembodiments, the locking insert 77 and the locking rack 75 lock thecarriage in place when the teeth from the locking insert 77 engage withthe teeth of the locking rack 75. In some embodiments, in order totranslate the scanhead 33 along the scanning track 45, the userdepresses, pushes down on, or applies a downward force onto the scanheadsubassembly 23 that is enough to disengage the locking insert 77 fromthe locking rack 75. In some embodiments, when the locking insert 77 andthe locking rack 75 are engaged, the scanhead 33 cannot be translatedalong the scanning track 45. In some embodiments, the user locks thescanhead 33 in place by releasing (i.e., stops pushing down on orapplying a downward force to) the scanhead subassembly 23 to its initialposition (i.e., a depth of 0 cm), thereby causing the teeth of thelocking insert 77 to engage or mate with the teeth of the locking rack75. In some embodiments, the translation of the scanhead 33 is automatedand controlled by the computing device of the slider tactile sensingdevice 2100.

FIGS. 23A-B show an assembled and exploded view of the scanning scanheadsubassembly 23, respectively. In some embodiments, the scanheadsubassembly 23 comprises a scanning knob 21, scanhead 33, and a carriage35.

In some embodiments, the scanning knob 21 comprises a first retentionclip 43 a and a second retention clip 43 b. In some embodiments, thescanning knob 21 enables the user to translate the scanhead 33 along thescanning track 45. In some embodiments, the scanning knob 21 comprisesthe first retention clip 43 a and the second retention clip 43 b. Insome embodiments, the scanning knob 21 comprises the first retentionclip spring 67 a and the second retention clip spring 67 b. In someembodiments, the first retention clip spring 67 a and the secondretention clip spring 67 b are placed in between the scanning knob 21and first retention clip 43 a and the second retention clip 43 b,respectively, under some tension. In some embodiments, the firstretention clip 43 a comprises a first pin 79 a, as shown in FIG. 23B. Insome embodiments, the second retention clip 43 b comprises a second pin79 b, as shown in FIG. 23B. In some embodiments, the first pin 79 a isanchored into a first cavity 89 a of the scanhead 33. In someembodiments, the first foot 63 a rests on the first ledge 65 a that isfound within the first cavity 89 a. In some embodiments, the second foot63 b rests on the second ledge 65 b that is found within the secondcavity (not shown in FIG. 23B). In some embodiments, the first pin 79 ais anchored into a second cavity (not shown in FIG. 23B) of the scanhead33. In some embodiments, the first retention clip 43 a pivots on thefirst pin 79 a and compresses the first retention clip spring 67 a. Insome embodiments, the second retention clip 43 b pivots on the secondpin 79 b and compresses the second retention clip spring 67 b.

In some embodiments, the first retention clip 43 a and the secondretention clip 43 b are further held in place by use of a first plate 81a and a second plate 81 b. In some embodiments, the first plate 81 issecured to a posterior side of the scanhead subassembly 23, as shown inFIG. 23B. In some embodiments, the first plate 81 a is fastened to thesecond plate 81 b via a third bolt 85 c, a fourth bolt 85 d, a third nut87 c, and a fourth nut 87 d. In some embodiments, the third bolt 85 ctraverses the anterior surface of the second plate 81 b and the firstplate 81 a and is furthered fastened by the third nut 87 c, which isplaced and secured on the end of the third bolt 85 c that protrudes fromthe first plate 81 a. In some embodiments, the fourth bolt 85 dtraverses the anterior surface of the second plate 81 b and the firstplate 81 a and is furthered fastened by the fourth nut 87 d, which isplaced and secured on the end of the fourth bolt 85 d that protrudesfrom the first plate 81 a.

In some embodiments the first plate 81 a and the second plate 81 b siton or attach to the top surface of the scanhead 33, as shown in FIGS.22A-B. In some embodiments, the scanhead 33 is placed and/or fits withinthe inner frame of the carriage 35. In other words, in some embodiments,the carriage 35 wraps around the scanhead 33. In some embodiments, thescanhead 33 comprises a third ledge 65 c and a fourth ledge (not shownin FIG. 23B). In some embodiments, the first spring 71 a and the secondspring 71 b are located within the carriage 35. In some embodiments, thedistal end of the first spring 71 a sits on the fourth ledge (not shownin FIG. 23B) of the carriage 35, and the distal end of the second spring71 a sits on the third ledge 65 c of the carriage 35. In someembodiments, the proximal end of the first spring 71 a and the secondspring 71 b contact the distal surface of the scanhead 33. Thus, in someembodiments, the first spring 71 a and the second spring 71 b arelocated in between the scanhead 33 and the carriage 35.

In some embodiments, the distal surface of the scanhead 33 comprises thesensor array. In some embodiments, the scanhead 33 comprises a base 83.In some embodiments, the base 83 secures the distal end of the scanhead33. In some embodiments, the base 83 wraps around the distal end of thescanhead 33, as shown in FIG. 22A. In some embodiments, the base 83 isfastened to the scanhead 33 via a first bolt 85 a, a second bolt 85 b, afirst nut 87 a, and a second nut 87 b. In some embodiments, the firstbolt 85 a traverses the lateral surface of the base 83 and is furtheredfastened by the first nut 87 a, which is placed and secured on the endof the first bolt 85 a that protrudes from the base 83, once the bolt isinserted through the base 83. Similarly, in some embodiments, the secondbolt 85 b traverses the lateral surface of the base 83 that is directlyopposite to the lateral surface in which the first bolt 85 a wasinserted. In some embodiments, the second bolt 85 b is furtheredfastened by the second nut 87 b, which is placed and secured on the endof the second bolt 85 b that protrudes from the base 83, once the boltis inserted through the base 83.

Scanhead

In some embodiments, the slider design comprises a scanhead 33. In someembodiments, the scanhead 33 is mated to the carriage 35 and moved alongthe scanning track 45. In some embodiments, the scanhead is depressedrelative to the carriage in order to better displace tissue andfacilitate imaging. In some embodiments, a first spring and a secondspring are strategically placed on the interior, anterior, and posterioredges of the scanhead, between the scanhead and the carriage. In someembodiments, the springs facilitate a range of about 3 centimeters (cm)of scanhead depression into the tissue. In some embodiments, thescanhead is depressed by applying downward pressure to the top of thescanhead. In some embodiments, the scanhead is moved along the scanningtrack by applying anterior or posterior pressure to the scanhead. Insome embodiments, the scanhead is a rolling scanhead, which is rotatedto travel the full length of the track. In some embodiments, the bottomsurface of the scanhead serves as a platform for a sensor array, asdescribed supra. In some embodiments, the sensor array has 11 rows and 9columns of sensels, with 1.9 mm spacing. In some embodiments, the sensorarray has 12 rows and 8 columns of sensels, with 1.9 mm spacing. In someembodiments, the bottom surface of the scanhead is curved. In someembodiments, the bottom surface of the scanhead has a curvature with aradius of about 75 mm opposite that of the vertebrae. In someembodiments, the bottom surface of the scanhead is about 20×16 mm. Insome embodiments, the bottom surface of the scanhead is about 30 mm×21mm. In some embodiments, the anterior and posterior edges of thescanhead are rounded to allow the scanhead to traverse more smoothlyalong the skin surface. In some embodiments, the anterior and posterioredges of the bottom of the scanhead are filleted with a diameter ofabout 8 mm, to allow the scanhead to traverse more smoothly along theskin surface. In some embodiments, edge softeners with fillets of about10 mm in diameter are connected to the anterior and posterior edges ofthe bottom surface of the scanhead. In some embodiments, the sensorarray is mounted to the bottom surface of the scanhead via an adhesive.In some embodiments, the tails of the sensor are tucked into clips onthe side of the carriage. In some embodiments, the tails of the sensorare aligned with registration holes on the interior or exterior anteriorand posterior faces of the scanhead.

In some embodiments, the scanhead 33 comprises a needle guide 2, asdescribed supra. In some embodiments, the needle guide is inside of thescanhead. In some embodiments, the needle guide is attached to thescanhead once a target tissue location is identified. In someembodiments, the bottom surface of the needle guide 2 serves as aplatform for a sensor array, as described supra. In some embodiments,the bottom surface of the needle guide serves as the distal opening ofthe needle guide, and is aligned with the slot in the sensor array. Insome embodiments, the proximal opening of the needle guide is alwaysexposed. In some embodiments, the needle guide is exposed by removing atop surface from the scanhead. In some embodiments, once the targettissue location is identified, the needle guide is exposed by rotatingthe scanhead. In some embodiments, once the target tissue location isidentified, the scanhead and mounted sensor array are removed to exposethe needle guide. In some embodiments, a release mechanism exists thatenables the device to be pulled away from the needle after insertion.

In some embodiments, the needle guide, as described supra, is locatedoutside of the scanhead. In some embodiments, the sensor array mountedto the bottom of the surface does not require a slot, as it is notmounted directly beneath the needle guide. In some embodiments, theneedle guide is located anterior or posterior to the scanhead. In someembodiments, the needle guide is laterally offset from the scanheadduring scanning. In some embodiments, the needle guide is fixed to thecarriage. In some embodiments, the needle guide is fixed to thescanhead. In some embodiments, the needle guide is attachable. In someembodiments, a cut exists on the interior of the frame to accommodatethe needle guide and allow the scanhead to complete its travel along thescanning track. In some embodiments, the proximal opening of the needleis always exposed. In some embodiments, once a target tissue location isidentified, the scanhead and carriage are manually moved along thescanning track until the needle guide aligns with the target tissuelocation. In some embodiments, once a target tissue location isidentified, the scanhead and carriage are automatically moved along thesliding track until the needle guide aligns with the target tissuelocation. In some embodiments, once the target tissue location isidentified, the scanhead is rotated to allow the needle guide to bealigned over the target tissue location. In some embodiments, once atarget tissue location is identified, the scanhead and carriage areremoved, and the needle guide is attached to the device so as to alignwith the target tissue location. In some embodiments, the device isdetached from the needle guide before insertion. In some embodiments, arelease mechanism exists that enables the device to be pulled away fromthe needle after insertion. In some embodiments, the needle is insertedat a location that is anterior to the scanhead 33. In some embodiments,the needle guide 2 is located on a surface (e.g., an anterior surface ora posterior surface) of the scanhead 33 rather than through the centerof the scanhead 33. In some embodiments, the needle is inserted at alocation that is posterior to the scanhead 33. In some embodiments, theneedle is not inserted through the scanhead 33. In other words, in someembodiments, the scanhead 33 does not comprise a needle guide 2traversing the center of the scanhead 33. In some embodiments, thescanhead 33 does not comprise the needle guide 2. For example, in someembodiments, the needle guide 2 is reversibly attached to the scanhead33. In some embodiments, the needle guide is not located through thecenter of the scanhead 33. In some embodiments, the scanhead does notcomprise a slot 38.

Scanning Knob

In some embodiments, the slider design comprises a scanning knob 21. Insome embodiments, the scanning knob is removable. In some embodiments,the scanning knob is fixed. FIGS. 24A-C show embodiment scanning knobsfor the tactile sensing device. In some embodiments, the scanning knobis part of the scanhead. In some assemblies, the scanning knob 21 isattached to the top surface of the scanhead. In some embodiments, thescanning knob 21 comprises ribs 91, as shown in FIG. 24A. In someembodiments, the scanning knob 21 does not comprise ribs. In someembodiments, the scanning knob is a convex scanning knob 37, as shown inFIG. 24B. In some embodiments, the convex scanning knob 37 is a scanningknob comprising a proximal surface (with respect to the user) that iscurved like the exterior of a circle and/or a sphere. In someembodiments, the convex scanning knob 37 comprises ribs. In someembodiments, the convex scanning knob 37 does not comprise ribs. In someembodiments, the scanning knob is a concave scanning knob 41, as shownin FIG. 24C. In some embodiments, the concave scanning knob 41 is a knobthat comprises a proximal surface (with respect to the user) that curvesinward like the interior of a circle and/or a sphere. In someembodiments, the concave scanning knob 37 comprises ribs. In someembodiments, the concave scanning knob 37 does not comprise ribs. Insome embodiments, the scanning knob 21 is used to move the scanhead andcarriage along the scanning track 45. In some embodiments, the scanningknob is used to move the scanhead proximally and distally (i.e. towardand away from the patient, respectively) relative to the carriage. Insome embodiments, the travel of the scanhead 33 along the scanningtrack, and proximal and distal movement are controlled by the samemechanism. In some embodiments, the travel of the scanhead 33 along thetrack and the travel of the scanhead 33 relative to the carriage arecontrolled by independent mechanisms. In some embodiments, movementrelative to the carriage prevents movement along the track. In someembodiments a pintle is used to lock the position of the carriage andscanhead during proximal and distal movement of the scanhead. In someembodiments, the scanning knob comprises a button that is configured torelease the scanhead from its locked position relative to the carriage.In some embodiments, the scanning knob comprises a button that isconfigured to release the carriage from its locked position along thetrack. In some embodiments, an indicator exists to alert to locking ofthe scanhead in its position along the track or relative to thecarriage. In some embodiments, movement of the scanhead is automated. Insome embodiments, movement of the scanhead is non-automated andcontrolled by a user. In some embodiments, movement of the scanhead iscontrolled by a user via buttons. In some embodiments, movement in theproximal and distal direction is controlled by a mechanism located atthe top of the scanning knob. In some embodiments, movement along thescanning track is controlled by a mechanism located on the side of thescanning knob. In some embodiments, movement along the scanning track iscontrolled by a user via push buttons. In some embodiments, the scanningknob is pushed proximally and distally to allow for travel relative tothe carriage. In some embodiments, the scanning knob is pushedanteriorly and posteriorly to allow for travel along the scanning track.In some embodiments, the scanning knob has a rotary dial that is rotatedto move the carriage along the scanning track 45. In some embodiments,the scanning knob has a rotary dial that is rotated to move the scanheadproximally and distally relative to the carriage. In some embodiments,the scanhead is moved relative to the carriage via a mechanicalactuator. In some embodiments, the scanhead is automatically movedrelative to the carriage to a level dictated by patient characteristics,such as body mass index (BMI). In some embodiments, the tactile sensingdevice comprises a mechanism that locks movement along the track andrelative to the carriage. In some embodiments, partial images ofcaptured areas are displayed while the scanning cycle is beingcompleted. In some embodiments, areas currently being acquired arehighlighted for clarity. In some embodiments, the scanning process ofthe slider workflow is most similar to the manual palpation-landmarkingprocess. In some embodiments, the scanning knob is removed to expose aneedle guide. In some embodiments, the scanning knob comprises at leastone scanning knob retention clip 43 a or 43 b to secure it to thescanhead 33, as shown in FIGS. 23A and 23B. In some embodiments,scanning knob retention clips are metal or plastic clips that mayinclude living springs or hinges. In some embodiments, scanning knobretention clips are secured to the scanhead. In some embodiments,scanning knob retention clips are pinched to disengage the scanningknob. In some embodiments, at least one button is included to detach thescanning knob. In some embodiments, the carriage 35 is fixed upondisengagement of the scanning knob.

Carriage

In some embodiments, the carriage 35 is reversibly secured around one ormore sides of the scanhead 33. In some embodiments, the carriage 35interacts with the locking rack 75 thereby causing the scanheadsubassembly 23 to lock in place. In some embodiments, the carriage 35contacts the scanning track 45, thereby enabling the scanhead 33 to betranslated along the scanning track 45. In some embodiments, thecarriage 35 is inserted into the scanning track 45 and used to traversea scanhead 33 along the spine. In some embodiments, the carriage ismagnetically mated to the track. In some embodiments, mating of thecarriage 35 with the scanning track 45 is further bolstered through theuse of pre-compressed springs. In some embodiments, silicone or othermaterials are used on the sliding surface between the carriage 35 andscanning track 45 to provide friction and support mating.

In some embodiments, the slider design comprises a position sensor (notshown in the figures). In some embodiments, the position sensor tracksthe position of the carriage 35 relative to the scanning track 45. Insome embodiments, the position sensor is a linear or multi-turn rotarypotentiometer. In some embodiments the position sensor is a magneticlinear encoder, such as, but not limited to a Hall-effect sensor. Insome embodiments, the position sensor is a potentiometer, with a wipercontact connected to a linear or rotational shaft, which forms anadjustable voltage divider relative to two end connections, and outputsa resistance proportional to wiper position along the shaft. In someembodiments, a reference voltage is applied across the fixed endconnections, and the output voltage is taken from the wiper contact asit moves along the shaft. In some embodiments, the output voltage isinputted to the PCBA in the UI module 1.

In some embodiments, the tactile sensing device comprises a computerprogram that converts the output voltage to a relative wiper position.In some embodiments the position sensor is a slide potentiometer, whichis integrated into the frame parallel to the scanning track 45, with thewiper inserted into a cut in the scanhead 33, such that the outputvoltage is proportional to the position of the scanhead 33 duringscanning. In some embodiments, the calculated position is displayed orreflected in the real-time pressure map 6. In some embodiments, theposition sensor is a linear potentiometer with a separate wiper attachedto the scanhead 33. In some embodiments, the position sensor is amulti-turn rotary potentiometer. In some embodiments, the positionsensor is a magnetic linear encoder, with one or more Hall-effectsensors in the frame. In some embodiments, the position sensor is anoptical linear encoder. In some embodiments, the position sensor is atime-of-flight sensor.

FIGS. 25A-B show an embodiment scanhead 33 comprising a needle guide 2having a proximal opening 134 a that tapers to the distal opening 134 b;FIG. 25B shows the scanhead 33 of FIG. 25A cut away through the needleguide 2. In some embodiments, the scanhead 33 comprises a slot 38, asshown in FIG. 25A. In some embodiments, the slot 38 comprises a firstslot wall 130 a (not shown in FIG. 25A) and a second slot wall 130 b(shown in FIG. 25A). In some embodiments, the slot 38 provides the userwith lateral access to the needle guide 2, as described elsewhere hereinin other embodiments. In some embodiments, the needle guide 2 comprisesa first needle guide wall 131 a and a second needle guide wall 131 b, asshown in FIG. 25B. In some embodiments, the first needle guide wall 131a and a second needle guide wall 131 b connect and form the track 144 ofthe needle guide 2. In some embodiments, the needle guide is reversiblyattached to the tactile sensing device. In some embodiments, the needlecomprises a notch.

FIGS. 26A-D show the workflow of how a user utilizes the tactile sensingdevice 2900 comprising the slider design when imaging a target tissuelocation of a patient. In some embodiments, the tactile sensing devicecomprising a slider design comprises a reusable UI module, a sleeve, anda reusable charging station, as described supra. In some embodiments,the tactile sensing device comprises a UI module 1 and a scanning knob21 that are reversibly coupled to the main housing frame 19. In someembodiments, the user inserts the scanning knob 21 into the main housingframe 19 (i.e., into the scanhead 33). Next, in some embodiments, theuser visually locates the general area of the target tissue location(e.g., spinous processes). Next, in some embodiments, the user placesthe tactile sensing device on the skin surface of the patient, ensuringthe device is perpendicular to the target tissue location (e.g., thespine), as shown in FIG. 26A. FIG. 26B shows the user 28 applying aconstant downward pressure on the scanning knob 21, through the sensorarray, and onto the skin surface of the patient. In some embodiments,the user 28 translates the scanning knob 21 up and down over the skinsurface of the patient (e.g., over the spinous processes of thepatient).

In some embodiments, once the complete image of the target tissuelocation is acquired, the tactile sensing device prompts the user whenthe needle guide is at correct location, as shown in FIG. 26C. In someembodiments, upon correct alignment of the needle guide, the user 28detaches the scanning knob 21 by pulling it up in order to release itfrom the main housing frame 19, as shown in FIG. 26D. In someembodiments, the scanning knob is detached by pinching at least twoclips that releases the knob from the main housing frame 19. In someembodiments, the user locks the scanhead 33 in place by releasing thescanning knob from the main housing frame 19. In some embodiments,releasing the scanning knob from the main housing frame 19 exposes theneedle guide. Next, in some embodiments, the user proceeds to insert theneedle into the needle guide. In some embodiments, the tactile sensingdevice comprises a needle retention clip configured to keep the needleand device in place.

Kits

In some embodiments, a tactile sensing device kit comprises a disposableneedle; sleeve; subassembly comprising a main housing frame 19 andscanning track 45; and subassembly comprising a scanning knob, carriage,and scanhead. In some embodiments, a tactile sensing device kitcomprises a disposable needle; sleeve; power grip handle; andsubassembly comprising a main housing frame 19 and curved sensorapplicator. In some embodiments, the tactile sensing device kit consistsof sterilized and disposable components. In some embodiments, thetactile sensing device kit is packaged in a pre-sealed sterilized bag orblister tray. In some embodiments, the UI module is part of a reusablemain housing frame 19 and is not part of the tactile sensing device kit.In some embodiments reusable tactile sensing device components arehygienically cleaned.

Historical and Real Time Image Visualization

In some embodiments, the tactile sensing device comprises a computingdevice. In some embodiments, the computing device comprises a computerprogram. In some embodiments, the computer program is, for example,software, including computer algorithms, computer codes, and/orprograms, which manages the device's hardware and provides services forexecution of instructions such as real-time imaging. In someembodiments, the tactile sensing device comprises a computer algorithmto build up an image from at least two images. In some embodiments, thealgorithm takes as an input the type of tactile sensing device beingused. In some embodiments, the algorithm automatically determines thetype of tactile sensing device being used. In some embodiments, thealgorithm automatically selects image-display steps depending on thetype of tactile sensing device being used. In some embodiments, thealgorithm adjusts drive voltage based on a header in an equilibrationfile. In some embodiments, imaging is initiated by pressing atouchscreen or physical button. In some embodiments, imaging isautomatically initiated when the device is pressed against a skinsurface. In some embodiments, the algorithm drives the sensor array andcaptures sensor data for the current time. In some embodiments, thealgorithm applies a Gaussian filter to current data. In someembodiments, the algorithm determines the active area of the currentdata. In some embodiments, the active area of the current data isdetermined by obtaining an ordered list of data rows, ignoring rowsbelow a cutoff, and determining the indices of the largest contiguousregion of rows above a cutoff. In some embodiments, the active area ofthe current data is automatically determined based on known scanheadsize and current scanhead position. In some embodiments, currentscanhead position is determined from a position sensor, such as apotentiometer. In some embodiments, a polynomial approximation of thecurrent data is used in order to apply a flat-field correction to removeartifacts. In some embodiments, the current data are scaled between 0and 1 by dividing by the sum of the current data and mapping to thescale of displayed data for the previous time. In some embodiments,current displayed data is determined by finding the maximum for eachpixel when comparing the current data to the previous displayed data. Insome embodiments, the current displayed data is the cumulative sum ofpreviously displayed data. In some embodiments, the current displayeddata is then saved as the previous displayed data. In some embodiments,the current displayed data is displayed to the screen of the tactilesensing device. In some embodiments, an imaging cycle is completed whenthe full sensor array area has been rocked against the target tissuelocation. In some embodiments, an imaging cycle is completed when ascanhead has been translated along the full length of a scanning track45. In some embodiments, the active area is highlighted on the displayusing rectangular or circular patches. In some embodiments, thealgorithm displays a line corresponding to the midline. In someembodiments, the algorithm displays a crosshair corresponding to thelocation of the needle relative to the current display data. In someembodiments, the display screen displays an arrow indicating thedirection in which the tactile sensing device should be moved tolocalize the target tissue location. In some embodiments, the algorithmtakes as inputs a patient identifier, patient weight, and patientheight. In some embodiments, the algorithm can change screen brightnessbased on brightness input from a touchscreen or physical button. In someembodiments, the algorithm can change the colormap based on input from atouchscreen or physical button. In some embodiments, the algorithm takesas an input a sensitivity factor. In some embodiments, the sensitivityfactor is selected using a touchscreen or physical button, or a dial. Insome embodiments, the sensitivity factor is used to rescale the colormapof currently displayed data. In some embodiments the sensitivity factoris used to adjust the drive voltage. In some embodiments, thesensitivity factor is used as the cutoff in determining the active areaof current data. In some embodiments, sensitivity is automaticallyadjusted based on patient BMI, as inputted or calculated from height andweight. In some embodiments, the algorithm displays a splash screenbefore imaging is initiated. In some embodiments the user can press atouchscreen or physical button to access a menu of input items. In someembodiments, the user can scroll through menu items using touchscreen orphysical buttons or a dial. In some embodiments, the algorithm containssteps for equilibration and calibration of the sensor array. In someembodiments, the user can remove high points that show up in currentdisplayed data during application of no force by pressing a touchscreenor physical tare button. In some embodiments, the algorithmautomatically removes high points during zero-force application. In someembodiments, the user can refresh the current displayed data by pressinga touchscreen or physical refresh button. In some embodiments, thealgorithm can detect if the device is aligned with the midline. In someembodiments the algorithm uses position sensors, such as anaccelerometer, to detect if the device is aligned with the midline. Insome embodiments, the algorithm can alert the user to off-midlineimaging. In some embodiments, the algorithm can automatically refreshthe currently displayed data if it corresponds to off-midline imaging.In some embodiments, the algorithm can detect if the tactile sensingdevice has changed orientation or been moved laterally during an imagingcycle. In some embodiments the algorithm can detect device movementusing a position sensor, such as a potentiometer, or a magnetic oroptical sensor. In some embodiments, the algorithm can alert the user todevice movement during an imaging cycle. In some embodiments, thealgorithm can automatically refresh currently displayed data if itdetects incorrect device reorientation or movement.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. It is not intendedthat the invention be limited by the specific examples provided withinthe specification. While the invention has been described with referenceto the aforementioned specification, the descriptions and illustrationsof the embodiments herein are not meant to be construed in a limitingsense. Numerous variations, changes, and substitutions will now occur tothose skilled in the art without departing from the invention.Furthermore, it shall be understood that all aspects of the inventionare not limited to the specific depictions, configurations or relativeproportions set forth herein which depend upon a variety of conditionsand variables. It should be understood that various alternatives to theembodiments of the invention described herein may be employed inpracticing the invention. It is therefore contemplated that theinvention shall also cover any such alternatives, modifications,variations or equivalents. It is intended that the following claimsdefine the scope of the invention and that methods and structures withinthe scope of these claims and their equivalents be covered thereby.

EXAMPLES Example 1: Diagnostic Spinal Puncture Using a Tactile SensingDevice

A health care worker performing a spinal puncture on an obese subjectplaces the tactile sensing device on the lumbar region of the subject. Apressure map, viewed as a heat map by the health care worker, appears onthe display screen 4 of the tactile sensing device 100. The heat mapindicates bone structures, in this case spinous processes of the lumbarvertebrae, by representing these in red color base and indicatesnon-bone structures by representing these in a blue color base. Thetactile sensing device simultaneously computes a needle projection anddisplays it on the pressure map in real time as the health care workeradvances a needle into the subject. The health care worker adjusts thetactile sensing device's needle guide angle to a cephalad angle degreebetween 9° and 15°. After identifying a gap between two of the lumbarvertebrae, for example L2 and L3, the health care worker inserts aspinal needle into the tactile sensing device's needle guide. The healthcare worker uses the needle guide and the needle projection (adjusted inreal time) and heat map (shown in real time) on the screen tosimultaneously guide the needle into the subarachnoid space. The healthcare worker then collects the cerebrospinal fluid (CSF). Once all CSFsamples are collected, the health care worker uses the tactile sensingdevice's 100 electronic pressure sensor, which automatically displaysthe CSF pressure on the display screen in real time, to measure andrecord the subject's intracranial pressure.

Example 2: Epidural Administration of a Therapeutic Using a TactileSensing Device

A health care worker performing an epidural administration of ananesthetic on a pregnant patient to places the tactile sensing device onthe lumbar region of the pregnant patient. A pressure map, viewed inreal time as a heat map by the health care worker, appears on thedisplay screen of the tactile sensing device. The heat map indicatesbone structures, in this case, spinous processes of the lumbarvertebrae, by representing these in a darker hue and indicates non-bonestructures by representing these in a lighter hue. The tactile sensingdevice simultaneously computes a projected subcutaneous needle locationin real time and displays it on the pressure map. The health care workeradjusts the tactile sensing device's needle guide track angle to acephalad angle degree between 0° and 15°. After identifying a gapbetween two of the lumbar vertebrae, for example L2 and L3, the healthcare worker inserts a spinal needle into the tactile sensing device'sneedle guide from the proximal opening of the needle guide toward thedistal opening of the needle guide, which is closest to the patient,aligning the needle in a track of the needle guide. In the epiduralcase, the health care worker optionally attaches a loss-of-resistancesyringe to the needle hub, to better detect epidural-space entry beforeor after placement of the needle into the needle guide. The health careworker uses the projected subcutaneous needle location, the originalneedle insertion site, and the heat map, both shown in real time andcontinuously adjusting their output (i.e. voltage data and needlelocation), displayed on the display screen to guide the needle into theepidural space and inject the anesthetic. The device is removed by thehealth care worker prior to removing the needle from the patient bymoving the device such that the needle tracks along the slot of thedevice, which slot connects to the needle guide.

Example 3: Epidural Administration of a Therapeutic Using a TactileSensing Device Having a Notch

A health care worker performing an epidural administration of ananesthetic on a pregnant patient to places the tactile sensing device onthe lumbar region of the pregnant patient. A pressure map, viewed inreal time as a heat map by the health care worker, appears on thedisplay screen of the tactile sensing device. The heat map indicatesbone structures, in this case, spinous processes of the lumbarvertebrae, by representing these in a darker hue and indicates non-bonestructures by representing these in a lighter hue. The tactile sensingdevice simultaneously computes a projected subcutaneous needle locationin real time and displays it on the pressure map. The health care workeradjusts the tactile sensing device's needle guide track angle to acephalad angle degree between 0° and 15°. After identifying a gapbetween two of the lumbar vertebrae, for example L2 and L3, the healthcare worker inserts a spinal needle into the notch of a tactile sensingdevice's needle guide, aligning the needle in a track of the needleguide. In the epidural case, the health care worker optionally attachesa loss-of-resistance syringe to the needle hub, to better detectepidural-space entry before or after placement of the needle into theneedle guide. The health care worker uses the projected subcutaneousneedle location, the original needle insertion site, and the heat map,both shown in real time and continuously adjusting their output (i.e.voltage data and needle location), displayed on the display screen toguide the needle into the epidural space and inject the anesthetic. Thedevice is removed by the health care worker prior to removing the needlefrom the patient by moving the device such that the needle overcomes thelip of the notch and thereafter tracks along the slot of the device.

What is claimed is:
 1. A tactile sensing device, comprising a scanheadsub-assembly comprising: a scanhead comprising a sensor array, thesensor array comprising: a first sensor comprising a first surface, asecond sensor comprising a second surface, wherein the first sensor isconfigured to output a first voltage signal in response to a firstchange in a first pressure applied to the first surface, and the secondsensor is configured to output a second voltage signal in response to asecond change in a second pressure applied to the second surface; and aneedle guide comprising a proximal opening and a distal opening, and aneedle guide track therebetween, and a frame to which the scanheadsub-assembly is moveably coupled, wherein the scanhead comprises anundepressed position and a depressed position, the depressed positionbeing distal to the frame as compared to the undepressed position. 2.The tactile sensing device of claim 1, wherein the scanhead sub-assemblyfurther comprises a biasing element that biases the scanhead in theundepressed position.
 3. The tactile sensing device of claim 2, whereinthe biasing element is a spring.
 4. The tactile sensing device of claim1, wherein the scanhead sub-assembly further comprises a lock configuredto lock a position of the scanhead or the needle guide relative to theframe.
 5. The tactile sensing device of claim 4, wherein the lock is apintle locking mechanism or a sawtooth locking mechanism.
 6. The tactilesensing device of claim 1, wherein the scanhead sub-assembly furthercomprises a lock configured to lock a position of the scanhead or theneedle guide relative to a length of the frame when the scanhead is inthe depressed position.
 7. The tactile sensing device of claim 1,wherein the scanhead sub-assembly further comprises a scanning knob,wherein the scanning knob is attached to the scanhead and configured toenable a user to move the scanhead.
 8. The tactile sensing device ofclaim 1, wherein the scanhead or the needle guide is configured to betranslated along a length of the frame.
 9. The tactile sensing device ofclaim 1, wherein the tactile sensing device further comprises a positionsensor configured to track the position of the scanhead or the needleguide relative to the frame.
 10. The tactile sensing device of claim 1,wherein the needle guide is configured to receive the needle or amarking tool.
 11. The tactile sensing device of claim 1, wherein theneedle guide further comprises a securing mechanism configured toaccommodate a plurality of needle gauges.
 12. The tactile sensing deviceof claim 1, wherein the needle guide is angled at a treatment angle thatis fixed.
 13. The tactile sensing device of claim 1, wherein the needleguide is angled at a treatment angle that is adjustable.
 14. The tactilesensing device of claim 1, wherein the needle guide is reversiblyattached to the scanhead.
 15. The tactile sensing device of claim 1,wherein the needle guide has a slot that is that enables the tactilesensing device to be pulled away from the needle.
 16. The tactilesensing device of claim 15, wherein the needle guide further comprises agate engageable by a user, the gate preventing the needle from slidingout of the slot or the needle guide track when the gate is engaged. 17.The tactile sensing device of claim 1, wherein the scanhead sub-assemblyfurther comprises a carriage configured to receive the scanhead.
 18. Thetactile sensing device of claim 17, wherein the scanhead is configuredto be depressed relative to the carriage.
 19. The tactile sensing deviceof claim 1, wherein the sensor array is adhered to a posterior surfaceof the scanhead.
 20. A tactile sensing system comprising: a tactilesensing device, comprising a scanhead sub-assembly comprising: ascanhead comprising a sensor array comprising: a first sensor comprisinga first surface, a second sensor comprising a second surface, whereinthe first sensor is configured to output a first voltage signal inresponse to a first change in a first pressure applied to the firstsurface, and the second sensor is configured to output a second voltagesignal in response to a second change in a second pressure applied tothe second surface; and a needle guide comprising a proximal opening anda distal opening, and a needle guide track therebetween, and a frame towhich the scanhead sub-assembly is moveably coupled, wherein thescanhead comprises an undepressed position and a depressed position, thedepressed position being distal to the frame as compared to theundepressed position; a fluid pressure sensor; and a display operativelycoupled to the sensor array configured to display a pressure maprepresenting a tissue location in an individual based upon the firstvoltage signal and the second voltage signal from the sensor array.